Primary Device ID | 10603295248941 |
NIH Device Record Key | ce595b34-09f2-4671-8c6b-664a24d842ed |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SPECIALIST |
Version Model Number | 96-6565 |
Catalog Number | 966565 |
Company DUNS | 080506581 |
Company Name | DEPUY ORTHOPAEDICS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10603295248941 [Primary] |
FSM | TRAY, SURGICAL, INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
[10603295248941]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2021-07-08 |
Device Publish Date | 2018-09-24 |
10603295248613 | SPECIALIST 2 STEINMAN PIN INSERTER |
10603295248279 | SPECIALIST 2 POLYETHYLENE TIBIAL COMPONENT IMPACTOR |
10603295248262 | SPECIALIST 2 TIBIAL TRAY INSERTER |
10603295251460 | SPECIALIST 2 SP2 PAT PLANER BLDE/CTR DRL LG |
10603295251453 | SPECIALIST 2 SP2 PAT PLANER BLDE/CTR DRL MED |
10603295251446 | SPECIALIST 2 SP2 PAT PLANER BLDE/CTR DRL SM |
10603295251699 | SPECIALIST 2 OFFSET MODULAR PLUS TIBIAL DRILL BUSHING SZ 4-5 |
10603295251682 | SPECIALIST 2 OFFSET MODULAR PLUS TIBIAL DRILL BUSHING SZ 1.5-3 |
10603295249948 | SPECIALIST 2 THREE PEG ROUND PATELLAR DRILL GUIDE 38mm, 41mm |
10603295249931 | SPECIALIST 2 THREE PEG ROUND PATELLAR DRILL GUIDE 32mm, 35mm |
10603295249665 | SPECIALIST 2 SINGLE PEG OVAL PATELLAR DRILL GUIDE 38mm, 41mm |
10603295249658 | SPECIALIST 2 SINGLE PEG OVAL PATELLAR DRILL GUIDE 32mm, 35mm |
10603295249511 | SPECIALIST 2 INSET PATELLA CLAMP |
10603295249221 | SPECIALIST 2 PATELLAR DRILL GUIDE SZ 32 & 35mm |
10603295249214 | SPECIALIST 2 PATELLAR DRILL GUIDE SZ 38 & 41mm |
10603295248668 | SPECIALIST 2 REFERENCE GUIDE |
10603295248217 | SPECIALIST 2 CEMENTED MODULAR PUNCH GUIDE DRILL BUSHING SZ 4-6 15mm |
10603295248200 | SPECIALIST 2 NON-CEMENTED MOD PUNCH GDE DRILL BUSHING SZ 4-6 15mm |
10603295248194 | SPECIALIST 2 CEMENTED MODULAR PUNCH GUIDE DRILL BUSHING SZ 1.5-3 13mm |
10603295248187 | SPECIALIST 2 NON-CEMENTED MOD PUNCH GDE DRILL BUSHING SZ 1.5-3 13mm |
10603295247715 | SPECIALIST 2 FEMORAL HOLDING CLAMP |
10603295216605 | SPECIALIST PATELLAR CEMENTING CLAMP |
10603295218050 | SPECIALIST OVAL PATELLAR DRILL |
10603295252177 | SPECIALIST 2 OFFSET MOD PLUS TIB INST-NON-CEMENTED INS |
10603295252160 | SPECIALIST 2 OFFSET MOD PLUS TIBIAL INSTRUMENT-CEMENTED INSERT |
10603295251545 | SPECIALIST 2 PATELLAR PLANER INSTRUMENT TRAY |
10603295251705 | SPECIALIST OFFSET MOD PLUS TIB INST AND TRIALS STERI TRAY |
10603295249139 | SPECIALIST 2 FLUTED FEM/TIB STEM TRLS STERIL TRAY |
10603295249122 | SPECIALIST 2 CEM FEM/TIB STEM TRLS STERIL TRAY |
10603295249115 | SPECIALIST 2 SPACER BLOCKS STERIL TRAY |
10603295249108 | SPECIALIST 2 FEMORAL AUGMENT TRLS INSTR STERIL TRAY |
10603295249092 | SPECIALIST 2 REAMERS AND SLEEVES STERIL TRAY |
10603295249085 | SPECIALIST 2 TIBIAL REVISION AND WEDGE TRL STERIL TRAY |
10603295249078 | SPECIALIST 2 FEM REVISION INST STERIL TRAY |
10603295249054 | SPECIALIST 2 STAB PLUS TIB INS TRIALS STERILIZATION TRAY-INS |
10603295249047 | SPECIALIST 2 STAB PLUS TIB INS TRLS STERILIZATION TRAY-BASE |
10603295249030 | SPECIALIST 2 BASE FEMORAL INSTRUMENTS HOLD DOWN |
10603295249023 | SPECIALIST 2 TC3 TIB INSERT STERIL TRAY INSERT |
10603295249016 | SPECIALIST 2 TC3 TIB INS TRIALS STERILIZATION TRAY-BASE ONLY |
10603295249009 | SPECIALIST 2 STAB TIBIAL INSERT TRLS STERIL INSERT TRAY |
10603295248996 | SPECIALIST 2 STAB TIB INSERT TRLS STERILIZATION TRAY-BASE |
10603295248989 | SPECIALIST 2 FEM FULL GENERIC STERIL TRY INSERT - FEM COMP TRL BASE |
10603295248972 | SPECIALIST 2 GENERAL INSERT STERIL TRY INSERT - PATELLA BASE |
10603295248965 | SPECIALIST 2 HALF GENERIC STERIL TRY INSERT - BASE TIBIAL |
10603295248958 | SPECIALIST 2 CEM MOD PUNCH STERIL TRY INSERT - BASE TIBIAL |
10603295248941 | SPECIALIST 2 NON-CEMENTED MOD PUNCH STERIL TRY INSRT BASE TIB |
10603295248934 | SPECIALIST 2 CRUCIFORM KEEL STERIL TRAY INSERT - BASE TIBIAL |
10603295248910 | SPECIALIST 2 PLI & CVD TIB INSERT TRIALS STERILIZATION TRAY SZ 1.5-4 |
10603295248903 | SPECIALIST 2 PLI & CVD TIB INSERT TRIALS STERILIZATION TRAY |
10603295248897 | SPECIALIST 2 BASE TIB INST STERILIZATION TRAY - BASE ONLY |