| Primary Device ID | 10603295431145 |
| NIH Device Record Key | cdeb43e6-7bda-47c8-98ba-40c593be391e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DEPUY REACH |
| Version Model Number | 9505-05-157 |
| Catalog Number | 950505157 |
| Company DUNS | 989365556 |
| Company Name | DEPUY (IRELAND) |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295431145 [Primary] |
| HTZ | INSTRUMENT, CUTTING, ORTHOPEDIC |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10603295431145]
Moist Heat or Steam Sterilization
[10603295431145]
Moist Heat or Steam Sterilization
[10603295431145]
Moist Heat or Steam Sterilization
[10603295431145]
Moist Heat or Steam Sterilization
[10603295431145]
Moist Heat or Steam Sterilization
[10603295431145]
Moist Heat or Steam Sterilization
[10603295431145]
Moist Heat or Steam Sterilization
[10603295431145]
Moist Heat or Steam Sterilization
[10603295431145]
Moist Heat or Steam Sterilization
[10603295431145]
Moist Heat or Steam Sterilization
[10603295431145]
Moist Heat or Steam Sterilization
[10603295431145]
Moist Heat or Steam Sterilization
[10603295431145]
Moist Heat or Steam Sterilization
[10603295431145]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-05-03 |
| Device Publish Date | 2018-09-24 |
| 10603295442325 | DEPUY REACH FEMORAL INSERTER |
| 10603295431282 | DEPUY REACH FEMORAL INSERTER |
| 10603295445272 | DEPUY REACH KNEE CASE 4 CRUCIATE - RETAINING |
| 10603295442349 | DEPUY REACH KNEE CASE 2 |
| 10603295442332 | DEPUY REACH KNEE CASE 1 |
| 10603295442288 | DEPUY REACH ALL POLY TIBIAL IMPACTOR |
| 10603295442257 | DEPUY REACH FB TIBIAL TRAY TRIAL SIZE 5 |
| 10603295431251 | DEPUY REACH FB TIBIAL TRAY TRIAL SIZE 4 |
| 10603295431244 | DEPUY REACH FB TIBIAL TRAY TRIAL SIZE 3 |
| 10603295431237 | DEPUY REACH FB TIBIAL TRAY TRIAL SIZE 2.5 |
| 10603295431220 | DEPUY REACH FB TIBIAL TRAY TRIAL SIZE 2 |
| 10603295431213 | DEPUY REACH FB TIBIAL TRAY TRIAL SIZE 1.5 |
| 10603295442240 | DEPUY REACH NOTCH GUIDE SIZE 5 |
| 10603295442233 | DEPUY REACH A-P CHAMFER CUT BLOCK SIZE 5 |
| 10603295431572 | DEPUY REACH SPACER BLOCK 10, 12.5, 15 |
| 10603295431466 | DEPUY REACH NOTCH GUIDE SIZE 4 |
| 10603295431459 | DEPUY REACH NOTCH GUIDE SIZE 3 |
| 10603295431442 | DEPUY REACH NOTCH GUIDE SIZE 2.5 |
| 10603295431435 | DEPUY REACH NOTCH GUIDE SIZE 2 |
| 10603295431428 | DEPUY REACH NOTCH GUIDE SIZE 1.5 |
| 10603295431398 | DEPUY REACH MOD TIBIAL CEMENTED PUNCH GUIDE SIZE 4-6 |
| 10603295431381 | DEPUY REACH MOD TIBIAL CEMENTED PUNCH GUIDE SIZE 1.5-3 |
| 10603295431350 | DEPUY REACH KEEL TIBIAL PUNCH GUIDE SIZE 1.5-4 |
| 10603295431299 | DEPUY REACH FEMORAL SIZING ROTATION GUIDE |
| 10603295431206 | DEPUY REACH EXTRA-MEDULLARY TIBIAL PROXIMAL UPROD |
| 10603295431190 | DEPUY REACH EXTRA-MEDULLARY TIBIA DISTAL CLAMP |
| 10603295431183 | DEPUY REACH EXTRA-MEDULLARY TIBIA DISTAL BODY |
| 10603295431176 | DEPUY REACH EXTRA-MEDULLARY TIBIA ANKLE BAND |
| 10603295431169 | DEPUY REACH DISTAL FEMORAL JIG OUTRIGGER |
| 10603295431152 | DEPUY REACH DISTAL FEMORAL JIG |
| 10603295431145 | DEPUY REACH DISTAL FEMORAL CUTTING BLOCK |
| 10603295431138 | DEPUY REACH ALIGNMENT ROD |
| 10603295431121 | DEPUY REACH A-P CHAMFER CUT BLOCK SIZE 4 |
| 10603295431114 | DEPUY REACH A-P CHAMFER CUT BLOCK SIZE 1.5 |
| 10603295431107 | DEPUY REACH A-P CHAMFER CUT BLOCK SIZE 3 |
| 10603295431091 | DEPUY REACH A-P CHAMFER CUT BLOCK SIZE 2.5 |
| 10603295431084 | DEPUY REACH A-P CHAMFER CUT BLOCK SIZE 2 |
| 10603295431077 | DEPUY REACH TIBIAL CUTTING BLOCK 3 DEGREE |
| 10603295431060 | DEPUY REACH FIXED TIBIAL STYLUS 2mm 8mm |
| 10603295431053 | DEPUY REACH SPACER BLOCK 1mm EXTENSION SHIM |
| 10603295431411 | DEPUY REACH MOD TIBIAL CEMENTED PUNCH SIZE 4-5 |
| 10603295431404 | DEPUY REACH MOD TIBIAL CEMENTED PUNCH SIZE 1.5-3 |