13m~e TECHNICAL FILE - DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2

Revision: 2

REF: SOP 2.1 .2 TECHNICAL FILE PROCEDURE Date Issued: 04/21/11 Page: I of 16

Technical File - Declaration of Conformity Technical File: Trauma Fixation Instrumentation

Authoritl·d Europrau Community \\\•till• :\lanufal'IUrl'I": Rrprrsrulath rand l.orntion of

lks >011sihll• l'rrson: Biomet Trauma PO Box 587 56 East Bell Drive Warsaw, IN 46581-0587 USA ~800-348-9500

Biomet U.K. Limited Waterton Industrial Estate South Wales Bridgend CF 31 3XA United Kingdom ct..44-1656-655221 11144-1656-645454

We hereby declare under our sole responsibility that the following products meet the classification, requirements, relevant directive provisions, harmonized standards, normative documents, registrations and certifications referenced below and within the technical file referenced above.

Orthopedic Instrumentation

Trauma Fixation Instrumentation

Part number listing below

Class Ila Per Rule 6 of Annex IX of the Council Directive 93/42/EEC concerning medical devices i.e. Medical Device Directive - MOD.

Council Directive 93/42/EEC and subsequent amendments concerning medical devices, i.e, Medical Device Directive - MOD:

Annex I Essential Re uirements Annex II EC Declaration of Conformi

Certificate No.

FMS798Sl Notified Bod

BSI Product Services Kitemark Court

EC Certificate - Full Assurance CMDCAS Certificate

Notified Bod No.: 0086

Declaration of Conformity Prepared Date: 18May1013

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 2 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

 

  

Catalog / Product No. Description GMDN Code 1001 4.8/6.5mm Step Drill 47563

1002 5.3MM DRILL BIT 47563

1069 CANNULATED REAMER 6.5MM 45115

1077 BALL NOSE GUIDEWIRE 3.0 35685

1127 EXCHANGE TUBE 47831

1138 3.8MM DRILL 47563

1253 TWIST DRILL 5.3MM X 6IN 47563

1285 3.8MM. CANNULATED REAMER 45115

1526 CALIBRATED DRILL 4.4MM 47563

1731 2.9MM CALIB.TWIST DRILL 47563

1735 HUMERAL ENTRY REAMER 45115

1741 3.8MM CALIB.TWIST DRILL 47563

1742 3.6/4.9MM CALIB.STEP DRIL 47563

1746 4.5/5.0 SOLID COUNTERSINK 16462

2617 3.8MM 3-FLUTE TRO.DRILBIT 47563

2619 3.8 3-F CAL.TRO.DRILL SQC 47563

2631 4.5MM SOLID LOCK DRIVER 33968

2645 5.3MM CALIB.DRILL QC 47563

13547 EASYOUT 47633

13548 CANNULATED COUNTERSINK 16462

13585 4.0 CANN.CANCEL. TAP 47562

14016 NON-ADJUSTABLE STEP DRILL 47563

14043 3.8MM DRILL BIT 47563

14447 5.5MM CANNULATED DRILL 47563

14541 4.5MM SOLID SCREWDRIVER 33968

14545 3.8MM SOLID DRILL 7IN 47563

14569 CALIBRATED LAG SCREW TAP 17507

14584 6.5MM SOLID CANCEL.TAP 47562

14616 6.5 SCREWDRIVER 33968

14620 EASY OUT 4.5/6.5 SCRW.SYS 47633

14621 3.8MM TWIST DRILL 47563

14622 3.8MM CANNULATED DRILL 47563

14623 4.5MM CORTICAL TAP 47562

14624 5.0MM CANCELLOUS TAP 47562

14625 4.8MM TWIST DRILL 47563

14626 4.8MM CANNULATED DRILL 47563

14627 6.5MM CANCELLOUS TAP 47562

14628 6.5MM COUNTERSINK 16462

14629 5.0MM CANNULATED DRILL 47563

14634 8.0MM CANCELLOUS TAP 47562

14663 SOLID SCREWDRIVER 3.5MM 33968

25008 REAMER 28MM 45115

25013 REAMER/TAP 28MM 17507

104059 2MM STEINMAN PIN 9IN 35685

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 3 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

Catalog / Product No. Description GMDN Code 107528 GUIDEWIRE 3.2MM X 28 35685

107538 GUIDEWIRE 3.2MM X 38 35685

140129 GUIDE WIRE 3.2X230MM 35685

141401 CANN HOLE SAW PRIMARY 14147

141403 CANN HOLE SAW SECONDARY 14147

141796 2MM X 6IN ST PIN HALF BAY PT 35685

141799 2MM X 9IN ST PIN HALF BAY PT 35685

141806 3.2MM X 6IN ST PIN HALF BAY PT 35685

145851 ADJUST.REAMER-SHORT 45115

145852 ADJUSTABLE REAMER MEDIUM 45115

145853 ADJUSTABLE REAMER-LONG 45115

172428 GUIDEWIRE 2.2MM X 28 35685

1354070 CANN.SCREWDRIVER 70MM 33968

1354270 SOLID SCREWDRIVER 70MM 33968

1355070 2.9 SOLID DRILL 70MM 47563

1355570 2.9 CANN. DRILL 70MM 47563

1356070 3.5 SOLID TWIST DRILL 70M 47563

1356470 4.0 SOLID TWIST DRILL 70M 47563

1357070 3.5 SOLID CORT.TAP 70MM 47562

1358070 4.0 SOLID CANCEL.TAP 70MM 47562

1401214 3.2MM X 14IN SHRT THRD GD PIN 35685

13540120 CANN SCREWDRIVER SHAFT 120MM 33968

13542120 SOLID SCREWDRIVER SHAFT 120MM 33968

13550120 2.9 SOLID DRILL, 120mm 47563

13560120 3.5 SOLID TWIST DRILL120M 47563

13564120 4.0 SOLID TWIST DRILL 120MM 47563

13570120 3.5 SOLID CORT.TAP 120MM 47562

13580120 4.0 CANCEL.TAP 120MM 47562

113909070 0.9X70MM PIN STE 35685

113910070 1.0MM DIA X 70MM KWIRE-STE(x3) 35685

113910100 K-WIRE 1.0X100MM STE 35685

113910170 1.0MM DIAX70MM KWIRE SNGL-STE 35685

113918062 1.8X52MM KATSUYA DRILL STE 43390

113920001 2.0mm CANN 1-STEP DRILL-STE 43390

113920002 2.0 SHORT CANN 1STEP DRILL-STE 43390

113920003 2.0MM CANN 1STEP DRILL OB-STE 43390

113920004 2.0MM DIA KATSUYA DRILL-STE 43390

113920011 2.2MM CANNULATED DRILL STE 43390

113920012 2.5MM AO DRILL STE 43390

113920013 2.5MM DRILL W/O LOCK STE 43390

113920062 2.0X62MM KATSUYA DRILL STE 43390

113925062 2.5X62MM CANNULATED DRILL STE 43390

113930062 3.0X62MM CANNULATED DRILL STE 43390

180010000 S S BIT 3-1/2X1/16 47563

180012000 S S BIT 3-1/2X5/64 47563

180014000 S S BIT 3-1/2X3/32 47563

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 4 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

Catalog / Product No. Description GMDN Code 180016000 S S BIT 3-1/2X7/64 47563

180018000 S S BIT 3-1/2X1/8 47563

180020000 S S BIT 3-1/2X9/64 47563

180022000 S S BIT 3-1/2X5/32 47563

180023000 S S BIT 3-1/2X11/64 47563

180024000 S S BIT 3-1/2X3/16 47563

180110000 S S BIT 5X1/16 47563

180112000 S S BIT 5X5/64 47563

180114000 S S BIT 5X3/32 47563

180116000 S S BIT 5X7/64 47563

180118000 S S BIT 5X1/8 47563

180120000 S S BIT 5X9/64 47563

180122000 S S BIT 5X5/32 47563

180123000 S S BIT 5X11/64 47563

180124000 S S BIT 5X3/16 47563

182110000 DRILL BIT 1/4X7 47563

182111000 DRILL BIT 5/16X7 47563

182112000 DRILL BIT 3/8X7 47563

210426000 GUIDE PIN 3.2MM BALL NOSE 35685

210428000 GUIDE PIN 3.2MM DRILL PT 35685

211201102 ENTRY REAMER SOLID SHAFT 45115

211201103 ENTRY REAMER FLEXIBLE SHAFT 35297

211201303 LAG SCREW DRILL 32390

211201309 5MM HEX DRIVER SET SCREW 33968

211201310 LAG SCREW TAP 17507

211201321 LAG SCREW DRILL 80/90MM 32390

211201405 4.3MML DISTAL GRADUATED DRILL 43390

211201406 4.3MMS DISTAL GRADUATED DRILL 43390

211201409 3.5MMS HEX DRIVER DISTAL SCREW 33968

211201410 4.3MM DRILL MEASURING SLEEVE 58148

211201411 4.3MML DISTAL GRADUATED DRILL JACOBS 43390

211201412 4.3MMS DISTAL GRADUATED DRILL JACOBS 43390

211201504 3.5MML HEX DRIVER AR/DIST SCRW 33968

211201505 A/R SCREW DRILL 43390

211201506 A/R SCREW REMOVAL TOOL 33968

211201507 A/R SCREW DRILL JACOBS 43390

211201509 CROWN ENTRY REAMER 45115

211201600 5MM HEX DRIVER END CAP 33968

211201601 5MM HEX CANN DRIVER END CAP 33968

211201602 END CAP REMOVAL TOOL 33968

212000002 SCREW DRIVER STE 58776

212000003 DEPTH GAUGE STE 58796

212000008 1.6MM KWIRE TROCHAR TIP STE 35685

212000010 DVR PLATE TEMPLATE SET STERILE 58804

212000022 2.2MM DRILL BIT STE 43390

212000122 2.2MM DRILL GUIDE STE 57789

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 5 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

Catalog / Product No. Description GMDN Code 212000222 SOFT TISSUE GUIDE 2.2MM 57789

212957010 DRILL BIT 2.8MM STERILE 43390

212957012 DRILL BIT 3.2MM STERILE 43390

212957014 DRILL BIT 4.0MM STERILE 43390

212957016 DRILL BIT 4.8MM STERILE 43390

212958010 CLAVICLE PIN 2.5MM TAP 17507

212958012 CLAVICLE PIN 3.0MM TAP 17507

212958014 CLAVICLE PIN 3.8MM TAP 17507

212958016 CLAVICLE PIN 4.5MM TAP 17507

214108001 ANCHOR BOLT 47847

214111001 4.5MM PERCUTANEOUS SCRWDRIVER 33968

214113032 3.2MM CALIBRATED DRILL BIT 47563

214113132 3.2x280MM CALIBRATED DRILL STE 43390

214114038 3.8MM CALIBRATED DRILL BIT 47563

214114138 3.8x280MM CALIBRATED DRILL STE 43390

214115000 4.5MM SOLID DRILL 47563

214115100 4.5x216MM DRILL STE 43390

214116000 4.5MM NONLOCKING CORTICAL TAP 47562

214116200 4.5x255 NONLOCK CORT TAP STE 56708

214116245 4.5x272MM LOCK CORT TAP STE 56708

214116545 4.5MM LOCKING CORTICAL TAP 47562

214121000 5.0MM CANN HEX DRIVER SHORT HD 33968

214123000 5.5MM CANNULATED DRILL BIT 47563

214123100 5.5X165MM CANN DRILL HD STE 43390

214126025 2.5 MM HEX EXTRACT HUDSON 47633

214126035 3.5 MM HEX EXTRACTOR HUDSON 47633

214126135 3.5 MM HEX EXTRACT LONG HUDSON 47633

214129000 2.5MM CALIBRATED DRILL BIT 47563

214129100 2.5X261MM CALIBRATED DRILL STE 43390

214141000 4.5 SCREWDRIVER S-CP 33968

214142000 CANN COUNTERSINK S-CP 16462

214143000 3.8MM CANN DRILL BLT S-CP 47563

214143100 3.8X150MM CANN DRILL STE 43390

214144000 4.5MM CANN DRILL BLT S-CP 47563

214144100 4.5X150MM CANN DRILL STE 43390

214145000 4.5MM CANN CORT TAP S-CP 47562

214145100 4.5MM CANN CORT TAP STE 56708

214146000 5.0MM CANN CANC TAP S-CP 47562

214146100 5.0MM CANN CANC TAP STE 56708

214202012 BALL SPIKE PUSHER 47874

214203038 3.8 CALIBRATED DRILL BIT 47563

214204007 PEAK FX LAG SCREW DRIVER 33968

214204023 PEAK FX KEY SCREW DRIVER 33968

214214001 5.0MM HEX DRIVER SHANK 33968

214214002 5.0MM CANNULATED DRILL 47563

214214012 5.0MM CANNULATED DRILL LONG AO 47563

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 6 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

Catalog / Product No. Description GMDN Code 214214300 GUIDE WIRE 3.2X300 35685

214215070 T-15 TAPERED DRIVER 33968

214226035 PEAK FX 3.5MM HEX EXTRACTOR 47633

214227070 2.7MM CALIB DRILL BIT 47563

214227071 2.7MM CALIB DRILL BIT 100MM 47563

214227160 2.7X160MM CALIBRATED DRILL STE 43390

214235006 2.7 MM DRILLBIT 100 MM 47563

214235007 2.5MM DRILL BIT 100 MM 47563

214235200 DRILL MEASURING SLEEVE 100 MM 47831

214288006 2.0 DRILL MEAS SLEEVE SHORT 47831

214288007 INSERT MULTI DIRECT 2.0MM 33968

214288008 MARKED DRILL BIT SHORT 2.0MM 47563

214288009 4.5MM CANC THREADED PIN AO 35685

231200101 1.7 MM SQUARE DRIVER 33968

231200102 1.7 MM SQUARE DRIVERMQC END 33968

231200200 2.2 MM DRILL BIT 47563

231200201 2.9 MM DRILL BIT 47563

231201300 DRILL BIT 3.3MM 43390

231201301 DRILL BIT F.A.S.T.2.0MM 43390

231201302 DRILL BIT 2.5MM 43390

231201303 STAINLESS STEEL K-WIRE 062 35685

231201306 DRILL F.A.S.T. 4.0MM LONG STE 43390

231201307 DRILL F.A.S.T 4.0MM SHORT STE 43390

231201308 DRILL F.A.S.T. 4.0MM STEP STE 43390

231201309 DRILL 2.8MM (DISTAL SCR) STE 43390

231201310 STAINLESS STEEL K-WIRE 2.0 STE 35685

231204006 SNP DRILL BIT JUMBO 47563

231204012 F A S T PEG DRIVER JUMBO 33968

231211001 INSERT CAPTIVE HEX 2.5MM 33968

231211002 MDTP DRIVER MINI QK CONNECT 33968

231218014 2.5 MM COUNTERBORE 16462

231218016 SHORT F.A.S.T. GUIDE 57789

231218021 T-15 TAPERED DRIVER SHORT 33968

231220200 1.0MM DRILL BIT MINI-QUICK CON 47563

231220201 1.3MM DRILL BIT MINI-QUICK CON 47563

231220202 FAST 1.1MM DRILLBIT MINIQUICK 47563

231220203 1.5MM DRILL BIT MINI-QUICK CON 47563

231220204 FAST 2.0MM DRILLBIT MINIQUICK 47563

231220205 2.5MM DRILL BIT MINI-QUICK CON 47563

231220206 1.3MM/1.5MM COUNTERSINK 47634

231220207 2.0MM/2.5MM COUNTERSINK 47634

231220208 1.3MM DRIVER BIT 47563

231220209 1.5MM DRIVER BIT 47563

231221200 1.0X56MM DRILL MQC STE 43390

231221201 1.3X56MM DRILL MQC STE 43390

231221202 1.1X56MM DRILL FAST MQC STE 43390

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 7 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

Catalog / Product No. Description GMDN Code 231221203 1.5X56MM DRILL MQC STE 43390

231221204 2.0X81MM DRILL FAST MQC STE 43390

231221205 2.5X81MM DRILL MQC STE 43390

246114447 5.5X150MM CANNULATED DRILL 43390

246114627 6.5MM CANN CANCELLOUS TAP STE 56708

246114629 5.0X150MM CANNULATED DRILL 43390

246114634 8.0MM CANN CANCELLOUS TAP STE 56708

246140129 3.2X230 THRD GUIDE PIN STE 35685

281001011 JIG BOLT DRIVER 5.0MM 33968

281001015 4.5/5.5MM SCREWDRIVER SHAFT 33968

281001016 COUNTERSINK SHAFT 16462

281001019 SOLIDLOK HEX TIP 3.5MM 47633

281001036 GUIDE PIN 3.6MM X 14 35685

281001037 5.0MM HEX DRIVER LONG 33968

281001041 3.6X355MM BAYONET GD PIN STE 35685

281001080 BALL NOSE GUIDE WIRE 80CM 35685

281001100 BALL NOSE GUIDE WIRE 100CM 35685

281001119 SOLIDLOK 3.5MM HEX TIP STE 58776

281001140 3.2X355MM THRD GUIDE PIN STE 35685

281001175 3.2X444MM THR GUIDE PIN STE 35685

281002015 150MM REAMER EXTENSION 45115

281002060 6MM MONOBLOC REAMER HUDSON 45115

281002065 6.5 MM MONOBLOC REAMER HUDSON 45115

281002070 7MM MONOBLOC REAMER HUDSON 45115

281002075 7.5MM MONOBLOC REAMER HUDSON 45115

281002080 8MM MONOBLOC REAMER HUDSON 45115

281002081 8MM MNBLC ENDCUT REAM HUDSON 45115

281002085 8.5MM MONOBLOC REAMER HUDSON 45115

281002090 9MM MONOBLOC REAMER HUDSON 45115

281002091 9MM MNBLC ENDCUT REAM HUDSON 45115

281002095 9.5MM MONOBLOC REAMER HUDSON 45115

281002100 10MM MONOBLOC REAMER HUDSON 45115

281002105 10.5MM MONOBLOC REAMER HUDSON 45115

281002110 11MM MONOBLOC REAMER HUDSON 45115

281002115 11.5MM MONOBLOC REAMER HUDSON 45115

281002120 12MM MONOBLOC REAMER HUDSON 45115

281002400 400MM NITINOL MOD REAMER HUDSN 35297

281002401 VERSA RMR 400MM CAPTRD SHAFT 35297

281002470 470MM NITINOL MOD REAMER HUDSN 35297

281002476 VERSA RMR 470MM CAPTRD SHAFT 35297

281003065 6.5MM MONOBLOC REAMER AO END 45115

281003070 7MM MONOBLOC REAMER AO END 45115

281003075 7.5MM MONOBLOC REAMER AO END 45115

281003401 VERSA RMR 400MM AO CAPTRD SHAFT 35297

281003476 VERSA RMR 470MM AO CAPTRD SHAFT 35297

281004090 9.0MM MODULAR REAMER HEAD 45115

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 8 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

Catalog / Product No. Description GMDN Code 281004091 VERSA 9MM END CUT MOD RMR HEAD 35297

281004095 9.5MM MODULAR REAMER HEAD 45115

281004100 10.0MM MODULAR REAMER HEAD 45115

281004105 10.5MM MODULAR REAMER HEAD 45115

281004110 11.0MM MODULAR REAMER HEAD 45115

281004115 11.5MM MODULAR REAMER HEAD 45115

281004120 12.0MM MODULAR REAMER HEAD 45115

281004125 12.5MM MODULAR REAMER HEAD 45115

281004130 13.0MM MODULAR REAMER HEAD 45115

281004135 13.5MM MODULAR REAMER HEAD 45115

281004140 14.0MM MODULAR REAMER HEAD 45115

281004145 14.5MM MODULAR REAMER HEAD 45115

281004150 15.0MM MODULAR REAMER HEAD 45115

281004155 15.5MM MODULAR REAMER HEAD 45115

281004160 16.0MM MODULAR REAMER HEAD 45115

281004165 16.5MM MODULAR REAMER HEAD 45115

281004170 17.0MM MODULAR REAMER HEAD 45115

281004175 17.5MM MODULAR REAMER HEAD 45115

281004180 18.0MM MODULAR REAMER HEAD 45115

281004185 18.5MM MODULAR REAMER HEAD 45115

281004190 19.0MM MODULAR REAMER HEAD 45115

281004195 19.5MM MODULAR REAMER HEAD 45115

281004200 20.0MM MODULAR REAMER HEAD 45115

281004205 20.5MM MODULAR REAMER HEAD 45115

281004210 21.0MM MODULAR REAMER HEAD 45115

281004215 21.5MM MODULAR REAMER HEAD 45115

281004220 22.0MM MODULAR REAMER HEAD 45115

281012002 11.5MM ENTRY REAMER TIBIA 45115

281012028 11.5MM ENTRY REAMER TIBIA 45115

281012038 3.8X150MM DRILL STE 43390

281012041 VERSA TIBIA STD COMPRESS ROD 47875

281012042 VERSA TIBIA EXTND COMPRESS ROD 47875

281012044 4.4X285MM DRILL STE 43390

281012138 3.8MM DRILL BIT 6IN NS 47563

281012144 4.4MM DRILL BIT NS 47563

281012238 3.8MM CAL DRILL 6IN NS JACOBS 47563

281012244 4.4MM CAL DRILL NS JACOBS 47563

281013001 12MM ENTRY REAMER FEMUR 45115

281013002 13MM ENTRY REAMER FEMUR 45115

281013003 14MM ENTRY REAMER FEMUR 45115

281013024 6.5MM SCREWDRIVER SHAFT 33968

281013028 13MM ENTRY REAMER FEMUR AO 45115

281013029 14MM ENTRY REAMER FEMUR AO 45115

281013037 FLEXIBLE JIG BOLT DRIVER 8MM 33968

281013038 3.8X210MM DRILL STE 43390

281013046 VERSA FEM UNIV COMPRESS ROD 47875

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 9 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

Catalog / Product No. Description GMDN Code 281013053 5.3X362MM DRILL STE 43390

281013065 6.5/4.8MMX363MM STEP DRILL STE 43390

281013138 3.8MM DRILL BIT 8IN NS 47563

281013153 5.3MM DRILL BIT NS 47563

281013165 6.5/4.8MM STEP DRILL BIT NS 47563

281013238 3.8MM DRILL BIT 8IN NS JACOBS 47563

281013453 5.3MM DRILL BIT NS JACOBS 47563

281013465 6.5/4.8MM STEP DRILL NS JACOBS 47563

281013553 5.3MM DRILL BIT NS 32390

281017003 UNIV NAIL ENTRY REAMER 9.4MM 45115

281017004 UNIVERSAL RETRO ENTRY REAMER 45115

281017006 2.0MM BALL NOSE GUIDE WIRE 35685

281017015 3.8MM DRILL BIT 43390

281017017 HUMERAL SCREWDRIVER 33968

281017019 2.9MM DRILL BIT 43390

281017022 UNIVERSAL NAIL EXTRACTOR BOLT 12696

281017024 COUNTERSINK 16462

281017026 Humeral Nail Exchange Tube Ste 57789

281017029 2.9MM DRILL BIT SHORT S 43390

281017115 3.8MM DRILL BIT 47563

281017119 2.9MM DRILL BIT 47563

281017129 2.9MM DRILL BIT SHORT NS 47563

281017215 3.8 CAL HUM DRILL NS JACOBS 47563

281017219 2.9 CAL HUM DRILL NS JACOBS 47563

281017229 2.9 CAL HUM DRILL 6IN NS JACBS 47563

281018002 PROX NAIL ENTRY REAMER 11.5MM 45115

290326000 DRILL BIT 2.7MM 47563

290328000 DRILL BIT 3.5MM 47563

290329000 DRILL BIT 1.5MM 47563

290330000 DRILL BIT 2.0MM 47563

290332000 DRILL BIT 3.2MM 47563

290336000 DRILL BIT 4.5MM 47563

330908050 0.8MM DIA X 50MM KWIRE-STE(x3) 35685

330918001 1.8DIA CANN 1-STEP DRILL-STE 43390

330918002 1.8DIA SHRT CANN 1STP DRIL-STE 43390

362120001 PACK PF1 - D12 48012

362120002 PACK PF2 - D12 48012

362120003 PACK EPIPHYSEAL - D12 48012

362120004 PACK ASSEMBLE BAR - D12 48012

362120005 PACK WRIST 48012

362180001 PACK PF1 - D18 48012

362180002 PACK PF2 - D18 48012

362180003 PACK EPIPHYSEAL - D18 48012

362180004 PACK ASSEMBLE BAR - D18 48012

363120150 PACK 1 CARBON BAR 12x150 48012

363120200 PACK 1 CARBON BAR 12x200 48012

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 10 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

Catalog / Product No. Description GMDN Code 363120250 PACK 1 CARBON BAR 12X250 48012

363120300 PACK 1 CARBON BAR 12X300 48012

363120350 PACK 1 CARBON BAR 12X350 48012

363120400 PACK 1 CARBON BAR 12X400 48012

363180250 PACK 1 CARBON BAR 18X250 48012

363180300 PACK 1 CARBON BAR 18X300 48012

363180350 PACK 1 CARBON BAR 18X350 48012

363180400 PACK 1 CARBON BAR 18X400 48012

809222028 GUIDEWIRE 2.2MM X 28IN 35685

809230028 GUIDEWIRE 3.0MMX28IN BALL 35685

809230038 GUIDEWIRE 3.0MM BALL NOSE 35685

809232228 GUIDEWIRE 3.2MM X 28IN 35685

809232238 GUIDEWIRE 3.2MM X 38IN 35685

810710000 SS PIN SELF DRILL TAP NS 35685

810710002 5.0X233MM SELF-DRILL PIN STE 35685

814099380 TI MINI 1.1MM DRILL BIT 47563

816299001 PROVISIONAL FIXATION PIN 20MM 35685

816299006 PROVISIONAL FIXATION PIN 40MM 35685

816299009 3.8MM CALIBRATED DRILL BIT 47563

816299010 4.5MM LOCKING CORTICAL TAP 47562

816299013 3.8MM SOLID DRILL BIT 47563

816299109 3.8x235MM CALIBRATED DRILL STE 43390

816299110 4.5X150MM LOCK CORT TAP STE 56708

816299113 3.8X173MM SOLID DRILL STE 43390

816301000 2.2 MM SQUARE DRIVER 33968

816301005 MEASURING DRILL SLEEVE 47831

816301009 2.0MM MARKED DRILL BIT 47563

816301016 2.0MM MEASURE DRILL SLEEVE 47831

820040000 5.3MMX13IN TWIST DRILL 47563

820508000 DRILL CANN ENTRY 13.5MM 47563

820711000 ENTRY REAMER 8.5MM 45115

820745004 3.8MM CALIBRATED TWIST DRILL 47563

820745038 3.8mm TTC DRILL STE 43390

820755004 4.4MM CALIBRATED TWIST DRILL 47563

820755044 4.4mm TTC DRILL STE 43390

821056000 3.5MM SCREWDRIVER 33968

821059000 EASY OUT 47633

821060000 3.0MM TREPHINE 14147

821061000 3.5MM TREPHINE 14147

821062000 4.5MM TREPHINE 14147

821063000 6.5MM TREPHINE 14147

821064000 3.5MM EXTRACTION BOLT 47633

821065000 4.5MM EXTRACTION BOLT 47633

821066000 6.5MM EXTRACTION BOLT 47633

821067000 3.5MM SCREW EXTRACTOR 47633

821068000 4.5MM SCREW EXTRACTOR 47633

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 11 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

Catalog / Product No. Description GMDN Code 821508000 LAG SCREW TAP REGULAR 47562

821509000 LAG SCREW TAP SUPER 47562

824135077 3.5MM LOCKING CORTICAL TAP 47562

824135177 3.5X140MM LOCK CORT TAP STE 56708

824150070 3.5 MM SOLID CORT TAP 70MM 47562

824150170 3.5X140MM CORTICAL TAP STE 56708

824156070 SCRDVR CANN S-CP 3.5MM 33968

824157071 SOLID SCREWDRIVER SHANK S-CP 33968

824158000 COUNTERSINK CANN SCOUPLE 16462

824158100 COUNTERSINK SMALL FRAG 16462

824159000 EASY OUT S-COUPLE 47633

824160070 TAP CORT S-CP 3.5X70MM 47562

824160120 TAP CORT S-CP 3.5X120MM 47562

824161070 TAP CANC S-CP 4.0X70MM 47562

824161120 TAP CANC SS-CP 4.0X120MM 47562

824161170 4.0X140MM CANCELLOUS TAP STE 56708

824161220 4.0X190MM CANCELLOUS TAP STE 56708

824162000 TAP CAN CANC SCP 4.0X70MM 47562

824162100 4.0X140MM CANN CANC TAP STE 56708

824167000 3.5MM CANN CORT TAP S-COUPLE 47562

824167100 3.5X140MM CANN CORT TAP STE 56708

824219000 4.5/6.5 SCR DRVR SHANK 33968

824220000 4.5/6.5 SOLID COUNTERSIN 16462

824220100 4.5/6.5 SOLID COUNTERSINK 16462

824245170 4.5X150MM CORTICAL TAP STE 56708

824272000 3.8MM SOLID DRILL BIT 47563

824273000 4.5MM SOLID DRILL BIT 47563

824273100 4.5X150MM Drill STE 43390

824274000 4.5MM SOLID CORTICAL TAP 47562

824275000 6.5MM SOLID CANC TAP 47562

824275100 6.5x195MM CANCELLOUS TAP STE 56708

824299000 PROVISIONAL FIXATION PIN SHORT 35685

824299001 PROVISIONAL FIXATION PIN LONG 35685

824299102 SFS PROV FIXATION PIN STE 35685

824299103 SFS PROV FIXATION PIN LONG STE 35685

829029070 DRILL BIT 2.5MM 47563

829029170 2.5X140MM DRILL STE 43390

829030070 DRILL CANN S-CP 2.9X70MM 47563

829030170 2.9X140MM CANN DRILL STE 43390

829031070 DRILL TWIST SCP 2.9X70MM 47563

829031120 DRILL TWIST SCP 2.9X120MM 47563

829031170 2.9X140MM DRILL STE 43390

829032009 3.2MM CALIBRATED GUIDE PIN 35685

829032070 DRILL TWIST SCP 3.5X70MM 47563

829032120 DRILL TWIST SCP 3.5X120MM 47563

829032170 3.5X140MM DRILL STE 43390

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 12 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

Catalog / Product No. Description GMDN Code 829032315 3.2X145MM DRILL STE 43390

829032382 2.0X120MM DRILL STE 43390

829033070 DRILL TWIST SCP 4.0X70MM 47563

829033170 4.0X140MM DRILL STE 43390

829034070 DRILL CANN SCP 3.5X70MM 47563

829034170 3.5X70MM CANN DRILL STE 43390

829131120 2.9X190MM DRILL STE 43390

829132009 3.2X230MM CALIBRATED PIN STE 35685

829516150 1.6X150 BAYONET GUIDE PIN STE 35685

829516151 1.6x150MM THRD GUIDE PIN STE 35685

833004004 2.5X444MM THRD GUIDEWIRE STE 35685

837820230 2.0x230MM THRD GUIDE WIRE STE 35685

839999185 2.5X230MM THRD GUIDE WIRE STE 35685

839999251 3.5X110MM DRILL STE 43390

839999254 4.0X110MM CANCELLOUS TAP STE 56708

839999316 4.5X145MM DRILL STE 43390

839999319 4.5X125MM CORTICAL TAP STE 56708

839999386 2.7X145MM CORTICAL TAP STE 56708

839999580 2.5X110MM DRILL STE 43390

839999586 3.5X110MM CORTICAL TAP STE 56708

851417960 2.0X150 BAYONET GUIDE WIRE STE 35685

856301005 MEASURING DRILL SLEEVE STE 58148

903001001 CANNULATED ENTRY REAMER 17MM 45115

903003004 3.2MM THREADED GUIDE PIN 35685

903003206 ATN LNG LAG SCREW STEP DRILL 47563

903004004 2.5 MM GUIDE PIN 35685

903004105 ATN AR SCREW STEP DRILL 47563

903005004 3.8 MM DRILL 47563

937418400 DRILL TIPP OLIVE WIRE 1.8x400 35685

939999184 GUIDE WIRE 2.5 X 300MM 35685

939999185 GUIDE PIN 2.5MM X 230MM 35685

939999188 COMBINATION REAMER SHORT 45115

939999189 COMBINATION REAMER LONG 45115

939999201 SCS COMBINATION REAMER 45115

939999312 3.5MM DRILL BIT (145/120MM) 32390

939999315 DRILL BIT 3.2 MM DIA. 32390

939999316 DRILL BIT 4.5 MM DIA. 32390

939999380 DRILL BIT 1.1 MM DIA QC 32390

939999381 DRILL BIT 1.5 MM DIA QC 32390

939999382 DRILL BIT 2.0 MM DIA QC 32390

939999383 DRILL BIT 2.7 MM DIA QC 32390

939999465 MINI SCREW MODULE 12143

939999580 DRILL BIT 2.5MM (GOLD) 32390

939999581 DRILL BIT 2.5MM (LONG) 32390

939999582 DRILL BIT 2.5MM (JACOBS CHUCK) 32390

939999583 DRILL BIT 3.5MM (LONG) 32390

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 13 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

Catalog / Product No. Description GMDN Code 939999584 DRILL BIT 3.5MM (JACOBS CHUCK) 32390

939999585 DRILL BIT 3.5MM LG.JAC.CHUCK 32390

939999713 DRILL BIT 2.7/1.35 CANN 32390

939999714 COUNTERSINK 4MM CANN SCREW 16462

939999716 2.5 SCREWDRIVER 4MM CANN SCRW 33968

939999717 MEASURING DEVICE 4MM CANN SCRW 32845

939999718 CLEANING BRUSH 1.35MM DIA 44802

939999719 STYLET, 1.25MM DIA 15275

939999725 CHS ONE STEP COUPLING SCREW 47847

939999750 CAN.4.5mm DRILL BIT 11332

A11523 DRILL BIT FOR 3MM PIN 47563

A3906 DRILL Ø3.5 – CANNULATED Ø1.7 MM 32390

A4162 DRILL Ø5.5 – CANNULATED Ø1.7 MM 32390

A4209 MECHE KATSUYA D2MM 32390

A4209ER KATSUYA DRILL D2MM QUICK C 32390

A5229 MECHE CANULEE COURTE 32390

A5232 MECHE CANULEE LONGUE 32390

A6311 PIN DIA 0.9MM – LENGTH 70MM 35685

A6312 KATSUYA DRILL DIAMETER 2MM 32390

A6313 THREADED PIN DIA 2MM – 70MM 46165

A6315 CANNULATED DRILL DIA 3.0MM 11332

DB20 DRILL BIT 2.0MM 47563

DB25 DRILL BIT 2.5MM 47563

DB28 DRILL BIT 2.8MM 47563

DB33 DRILL BIT 3.3MM 47563

DB40L DRILL BIT 4.0MM LONG 47563

DB40S DRILL BIT SHORT 4.0MM 47563

DBS40 DRILL BIT 4.0MM STEP 47563

FDB20 DRILL BIT FAST 2.0MM 47563

FDB40L DRILL BIT FAST 4.0MM LONG 47563

FDB40S DRILL BIT FAST 4.0MM SHORT 47563

FDS40 DRILL BIT FAST 4.0MM STEP 47563

FF10503 DRILL 5MM FISCHER 35647

FF10551 5MM TIP CAP 48011

GA1355070 BOHRER,DURCHM.2,9MM,LäNGE 70MM (2.9 SOLID DRILL 70MM) 47563

GA1355570 KANUL. BOHRER, DURCHM. 2,9X 70 (2.9 CANN. DRILL 70MM) 47563

GA1356070 BOHRER MIT AO-SCHNELLANSCHLUSS (3.5 SOLID TWIST DRILL 70MM) 47563

GA1356470 BOHRER MIT AO-SCHNELLANSCHLUSS (4.0 SOLID TWIST DRILL 70MM) 47563

GA14621 BOHRER, DURCHM. 3,8 MM (3.8MM TWIST DRILL) 47563

GG1355570 KANUL.BOHRER, DURCHM. 2,9MM, (2.9 CANN. DRILL 70MM) 47563

KW062 KWIRE 1.6MM TI 35685

KW062SS KWIRE 1.6MM SS 35685

KW20SS KWIRE 2.0MM SS 35685

M43850 BROCHE GUIDE 20/10 200 MM 46165

M43852 BROCHE GUIDE 25/10X200MM 46165

M43870 PT TARIERE D7 LG 185 45115

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 14 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

Catalog / Product No. Description GMDN Code M43872 GRANDE TARRIERE DIAM 14 200 MM 45115

M48500 BROCHE GUIDE 25/10X200MM 46165

M48550 REAMER 45115

M49200 BROCHE GUIDE 18/10 200 MM 46165

M49210 VISEUR GRADUE GLORION 35095

M49230 TARIERE D 5,5 MM GLORION 45115

M49250 TARIERE D 8,5 MM GLORION 45115

M68714 CORTICAL SCREW TAP Ø4.5 MM 17507

MDP015 MECHE DE PERCAGE 1.5 32390

MDP035 DRILL BIT 3.5MM DIA 32390

MDP045 DRILL BIT 4.5MM DIA 32390

MDP055 DRILL BIT 5.5MM DIA 32390

PA247 MEC PERCEE SCARF 2 INCL 32390

PA247ER SCARF DRILLBIT 2 INCL QUICK C 32390

PA248 SCARF DRILLBIT 2 INCL 32390

PA248ER SCARF DRILLBIT 2INCL QUICK C 32390

PA251 SCARF DRILLBIT 2 32390

PA374 DRILLBIT 2.5 MDF 2.2 32390

PA375 DRILLBIT 2.5 VERROU 32390

PA379 2.5 DRILL 32390

PA390 LAME SCIE WEIL/SYNTHES 44985

PA392 LAME DE WEIL TYPE SYNTHES 44985

PA395 LAME DE SCIE WEIL/ 44985

SNDB40 DRILL BIT SNP 4.0MM 47563

SNPG20 SHOULDER PIN GUIDE 2.0MM 57789

TC1 4MM TIP CAP 48011

TC2 3MM TIP CAP 48011

  

GMDN Code(s): 11332 – Cannulated Surgical Drill 12696 – Orthopeadic implant inserter/extractor 14147 – Bone Trephine 16462 – Surgical Countersink, reusable 17507 – Bone Tap, reusable 32390 – Non-Sterile fluted drill, reusable 33968 – Surgical screwdriver, reusable 35095 – Surgical drill guide, reusable 35297 – Medullary canal orthopaedic reamer, flexible 35647 – External Orthopaedic fixation system, reusable 35685 – Orthopaedic bone wire 43390 – Sterile fluted surgical drill 44802 – Orthopaedic instrument cleaning tool 44985 - Reciprocating surgical saw blade, reusable 45115 – Manual canal orthopaedic reamer, rigid 46165 – Bone Nail Guidewire 47562 – Bone tap, single use, non-sterile 47563 – Non-sterile fluted surgical drill, single-use

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 15 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

47633 – Surgical screwdriver, single-use, non-sterile 47634 – Surgical countersink, single-use 47831 – Surgical Instrument Sleeve Reusable 47847 – Orthopaedic implant/instrument adaptor, reusable 48011 – External Orthopeadic fixation system, single-use, non-sterile 48012 – External Orthopeadic fixation system, single-use, sterile 56708 – Bone tap, single-use, sterile 57789 – Surgical drill guide, single-use 58776 – Surgical screwdriver, single-use, sterile 58148 – Surgical instrument sleeve single-use 58796 – Surgical depth gage, single-use 58804 – Surgical implant template, single-use

   

TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 16 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE

Declaration of Conformity Prepared Date: 28 May 2013

 

 

 

REV. DATE DESCRIPTION OF CHANGE  1 05/25/10 New  2 04/21/11 Added additional column and note for GMDN codes for clarity.