| Primary Device ID | 10603295231301 |
| NIH Device Record Key | 9f8d823e-516f-4869-97fb-b58f72c19092 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | P.F.C. SIGMA RPF |
| Version Model Number | 95-9001 |
| Catalog Number | 959001 |
| Company DUNS | 896498813 |
| Company Name | DEPUY INTERNATIONAL LTD |
| 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 | |
| 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 | 10603295231301 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
[10603295231301]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-05-13 |
| Device Publish Date | 2018-09-24 |
| 10603295224136 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 6 RIGHT |
| 10603295224129 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 5 RIGHT |
| 10603295224112 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 4 RIGHT |
| 10603295224105 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 3 RIGHT |
| 10603295224075 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 1.5 RIGHT |
| 10603295224068 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 1 RIGHT |
| 10603295224051 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 6 LEFT |
| 10603295224044 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 5 LEFT |
| 10603295224013 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 2.5 LEFT |
| 10603295224006 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 2 LEFT |
| 10603295223993 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 1.5 LEFT |
| 10603295223986 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 1 LEFT |
| 10603295074809 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 4N LEFT |
| 10603295224099 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 2.5 RIGHT |
| 10603295224082 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 2 RIGHT |
| 10603295224037 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 4 LEFT |
| 10603295224020 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 3 LEFT |
| 10603295074816 | P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 4N RIGHT |
| 10603295231493 | P.F.C. SIGMA RPF INSTRUMENT CASE - INSTRUMENTS |
| 10603295231486 | P.F.C. SIGMA RPF INSTRUMENT CASE - TRIALS |
| 10603295231431 | P.F.C. SIGMA RPF SPACER BLOCK 10-17.5 |
| 10603295231301 | P.F.C. SIGMA RPF FEMORAL DISTRACTOR S-SHAPED |
| 10603295231387 | P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 6 |
| 10603295231370 | P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 5 |
| 10603295231363 | P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 4 |
| 10603295231356 | P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 3 |
| 10603295231349 | P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 2.5 |
| 10603295231332 | P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 2 |
| 10603295231325 | P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 1.5 |