| Primary Device ID | 00841690191803 |
| NIH Device Record Key | cbb764b0-7963-4dad-b77f-f08491fc086c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APEX Knee System |
| Version Model Number | KR-56210 |
| Catalog Number | KR-56210 |
| Company DUNS | 061339651 |
| Company Name | Omni Life Science, 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 | false |
| 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)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841690191803 [Primary] |
| HTW | BIT, DRILL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
[00841690191803]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-13 |
| Device Publish Date | 2023-01-10 |
| 00841690131816 | High Performance Revision Femur, Size 5+ Right, Cemented |
| 00841690131809 | High Performance Revision Femur, Size 5+ Left, Cemented |
| 00841690131779 | High Performance Revision Femur, Size 4+ Right, Cemented |
| 00841690131762 | High Performance Revision Femur, Size 4+ Left, Cemented |
| 00841690131731 | High Performance Revision Femur, Size 3+ Right, Cemented |
| 00841690131724 | High Performance Revision Femur, Size 3+ Left, Cemented |
| 00841690131694 | High Performance Revision Femur, Size 2+ Right, Cemented |
| 00841690131687 | High Performance Revision Femur, Size 2+ Left, Cemented |
| 00841690131656 | High Performance Revision Femur, Size 1+ Right, Cemented |
| 00841690131649 | High Performance Revision Femur, Size 1+ Left, Cemented |
| 00841690131632 | High Performance Revision Femur, Size 1 Right, Cemented |
| 00841690131625 | High Performance Revision Femur, Size 1 Left, Cemented |
| 00841690129653 | PS femur, uncemented Size 5+ Left |
| 00841690134336 | PS-R Insert, Size 5 x 28mm |
| 00841690134329 | PS-R Insert, Size 5 x 24mm |
| 00841690134312 | PS-R Insert, Size 5 x 20mm |
| 00841690134305 | PS-R Insert, Size 5 x 18mm |
| 00841690134299 | PS-R Insert, Size 5 x 16mm |
| 00841690134282 | PS-R Insert, Size 5 x 14mm |
| 00841690134275 | PS-R Insert, Size 5 x 12mm |
| 00841690134268 | PS-R Insert, Size 5 x 11mm |
| 00841690134251 | PS-R Insert, Size 5 x 10mm |
| 00841690134244 | PS-R Insert, Size 4 x 28mm |
| 00841690134213 | PS-R Insert, Size 4 x 18mm |
| 00841690134190 | PS-R Insert, Size 4 x 14mm |
| 00841690132905 | Primary Tibial Baseplate Cemented, Pegged, size 6 Right |
| 00841690132899 | Primary Tibial Baseplate Cemented, Pegged, size 6 Left |
| 00841690132882 | Primary Tibial Baseplate Cemented, Pegged, size 5 Right |
| 00841690132875 | Primary Tibial Baseplate Cemented, Pegged, size 5 Left |
| 00841690132868 | Primary Tibial Baseplate Cemented, Pegged, size 4 Right |
| 00841690132851 | Primary Tibial Baseplate Cemented, Pegged, size 4 Left |
| 00841690132844 | Primary Tibial Baseplate Cemented, Pegged, size 3 Right |
| 00841690132837 | Primary Tibial Baseplate Cemented, Pegged, size 3 Left |
| 00841690132820 | Primary Tibial Baseplate Cemented, Pegged, size 2 Right |
| 00841690132813 | Primary Tibial Baseplate Cemented, Pegged, size 2 Left |
| 00841690132806 | Primary Tibial Baseplate Cemented, Pegged, size 1 Right |
| 00841690132790 | Primary Tibial Baseplate Cemented, Pegged, size 1 Left |
| 00841690131977 | Congruent Tibial Insert, Size 1 x 12mm |
| 00841690131960 | Congruent Tibial Insert, Size 1 x 11mm |
| 00841690131953 | Congruent Tibial Insert, Size 1 x 10mm |
| 00841690131908 | Patella 35 mm x 10 mm |
| 00841690131373 | High Performance PS Femoral Component, Size 6+ Right, Cemented |
| 00841690131366 | High Performance PS Femoral Component, Size 6+ Left, Cemented |
| 00841690131359 | High Performance PS Femoral Component, Size 6 Right, Cemented |
| 00841690131342 | High Performance PS Femoral Component, Size 6 Left, Cemented |
| 00841690131335 | High Performance PS Femoral Component, Size 5+ Right, Cemented |
| 00841690131328 | High Performance PS Femoral Component, Size 5+ Left, Cemented |
| 00841690131311 | High Performance PS Femoral Component, Size 5 Right, Cemented |
| 00841690131304 | High Performance PS Femoral Component, Size 5 Left, Cemented |
| 00841690131298 | High Performance PS Femoral Component, Size 4+ Right, Cemented |