| Primary Device ID | 10603295119753 |
| NIH Device Record Key | a6a95cb7-7b14-40ac-a12d-7ea30a33aed0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AML |
| Version Model Number | 2354-04-000 |
| Catalog Number | 235404000 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295119753 [Primary] |
| HWR | DRIVER, PROSTHESIS |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10603295119753]
Moist Heat or Steam Sterilization
[10603295119753]
Moist Heat or Steam Sterilization
[10603295119753]
Moist Heat or Steam Sterilization
[10603295119753]
Moist Heat or Steam Sterilization
[10603295119753]
Moist Heat or Steam Sterilization
[10603295119753]
Moist Heat or Steam Sterilization
[10603295119753]
Moist Heat or Steam Sterilization
[10603295119753]
Moist Heat or Steam Sterilization
[10603295119753]
Moist Heat or Steam Sterilization
[10603295119753]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2018-09-24 |
| 10603295119753 | AML TRIAL IMPLANT DRIVER |
| 10603295058342 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 12.0mm LARGE STATURE 160mm LENGTH 40mm OFFSET |
| 10603295058328 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 10.5mm LARGE STATURE 160mm LENGTH 40mm OFFSET |
| 10603295058229 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 12.0mm SMALL STATURE 155mm LENGTH 40mm OFFSET |
| 10603295058205 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 10.5mm SMALL STATURE 155mm LENGTH 40mm OFFSET |
| 10603295058502 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 22.5mm LARGE STATURE HIGH OFFSET 155mm LENGTH 52mm OFFSE |
| 10603295058496 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 21.0mm LARGE STATURE HIGH OFFSET 155mm LENGTH 52mm OFFSE |
| 10603295058489 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 19.5mm LARGE STATURE HIGH OFFSET 160mm LENGTH 52mm OFFSE |
| 10603295058472 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 18.0mm LARGE STATURE HIGH OFFSET 160mm LENGTH 52mm OFFSE |
| 10603295058465 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 16.5mm LARGE STATURE HIGH OFFSET 160mm LENGTH 52mm OFFSE |
| 10603295058458 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 15.0mm LARGE STATURE HIGH OFFSET 160mm LENGTH 52mm OFFSE |
| 10603295058441 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 13.5mm LARGE STATURE HIGH OFFSET 160mm LENGTH 52mm OFFSE |
| 10603295058427 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 22.5mm LARGE STATURE 155mm LENGTH 45mm OFFSET |
| 10603295058410 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 21.0mm LARGE STATURE 155mm LENGTH 45mm OFFSET |
| 10603295058403 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 19.5mm LARGE STATURE 155mm LENGTH 45mm OFFSET |
| 10603295058397 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 18.0mm LARGE STATURE 155mm LENGTH 45mm OFFSET |
| 10603295058380 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 16.5mm LARGE STATURE 160mm LENGTH 45mm OFFSET |
| 10603295058373 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 15.0mm LARGE STATURE 160mm LENGTH 45mm OFFSET |
| 10603295058366 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 13.5mm LARGE STATURE 160mm LENGTH 45mm OFFSET |
| 10603295058359 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 12.0mm 6 Inches LARGE STATURE 160mm LENGTH 40mm OFFSET |
| 10603295058335 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 10.5mm 6 Inches LARGE STATURE 160mm LENGTH 40mm OFFSET |
| 10603295058304 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 22.5mm SMALL STATURE 150mm LENGTH 43mm OFFSET |
| 10603295058298 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 21.0mm SMALL STATURE 150mm LENGTH 43mm OFFSET |
| 10603295058281 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 19.5mm SMALL STATURE 150mm LENGTH 43mm OFFSET |
| 10603295058274 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 18.0mm SMALL STATURE 150mm LENGTH 43mm OFFSET |
| 10603295058267 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 16.5mm SMALL STATURE 150mm LENGTH 43mm OFFSET |
| 10603295058250 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 15.0mm SMALL STATURE 155mm LENGTH 43mm OFFSET |
| 10603295058243 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 13.5mm SMALL STATURE 155mm LENGTH 43mm OFFSET |
| 10603295058236 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 12.0mm 6 Inches SMALL STATURE 155mm LENGTH 40mm OFFSET |
| 10603295058212 | AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 10.5mm 6 Inches SMALL STATURE 155mm LENGTH 40mm OFFSET |