| Primary Device ID | 10603295231370 | 
| NIH Device Record Key | ac5b20ff-df06-4d80-a82f-67e78f872585 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | P.F.C. SIGMA RPF | 
| Version Model Number | 95-9008 | 
| Catalog Number | 959008 | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 10603295231370 [Primary] | 
| HWT | TEMPLATE | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[10603295231370]
Moist Heat or Steam Sterilization
[10603295231370]
Moist Heat or Steam Sterilization
[10603295231370]
Moist Heat or Steam Sterilization
[10603295231370]
Moist Heat or Steam Sterilization
[10603295231370]
Moist Heat or Steam Sterilization
[10603295231370]
Moist Heat or Steam Sterilization
[10603295231370]
Moist Heat or Steam Sterilization
[10603295231370]
Moist Heat or Steam Sterilization
[10603295231370]
Moist Heat or Steam Sterilization
[10603295231370]
Moist Heat or Steam Sterilization
[10603295231370]
Moist Heat or Steam Sterilization
[10603295231370]
Moist Heat or Steam Sterilization
[10603295231370]
Moist Heat or Steam Sterilization
[10603295231370]
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 | 
| 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 |