| Primary Device ID | 00841690104292 |
| NIH Device Record Key | 33e035f3-bf9a-4743-aedf-c65edd8bb928 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APEX CR Knee |
| Version Model Number | KC-1445L |
| Catalog Number | KC-1445L |
| Company DUNS | 061339651 |
| Company Name | Omnilife Science, Inc |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841690104292 [Primary] |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841690104292]
Ethylene Oxide
[00841690104292]
Ethylene Oxide
[00841690104292]
Ethylene Oxide
[00841690104292]
Ethylene Oxide
[00841690104292]
Ethylene Oxide
[00841690104292]
Ethylene Oxide
[00841690104292]
Ethylene Oxide
[00841690104292]
Ethylene Oxide
[00841690104292]
Ethylene Oxide
[00841690104292]
Ethylene Oxide
[00841690104292]
Ethylene Oxide
[00841690104292]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-11-27 |
| 00841690111726 | Retaining Bolt Congruent or Ultra, Modular Tibia Baseplate |
| 00841690104360 | CR Femoral Uncemented, Size 6 Right |
| 00841690104353 | CR Femoral Uncemented, Size 6 Left |
| 00841690104322 | CR Femoral Uncemented, Size 5 Right |
| 00841690104315 | CR Femoral Uncemented, Size 5 Left |
| 00841690104308 | CR Femoral Uncemented, Size 4+ Right |
| 00841690104292 | CR Femoral Uncemented, Size 4+ Left |
| 00841690104285 | CR Femoral Uncemented, Size 4 Right |
| 00841690104278 | CR Femoral Uncemented, Size 4 Left |
| 00841690104261 | CR Femoral Uncemented, Size 3+ Right |
| 00841690104254 | CR Femoral Uncemented, Size 3+ Left |
| 00841690104247 | CR Femoral Uncemented, Size 3 Right |
| 00841690104230 | CR Femoral Uncemented, Size 3 Left |
| 00841690104223 | CR Femoral Uncemented, Size 2+ Right |
| 00841690104216 | CR Femoral Uncemented, Size 2+ Left |
| 00841690104209 | CR Femoral Uncemented, Size 2 Right |
| 00841690104193 | CR Femoral Uncemented, Size 2 Left |
| 00841690104162 | CR Femoral Uncemented, Size 1 Right |
| 00841690104155 | CR Femoral Uncemented, Size 1 Left |
| 00841690104148 | CR Femoral Cemented, Size 7 Right |
| 00841690104131 | CR Femoral Cemented, Size 7 Left |
| 00841690102014 | Retaining Bolt Congruent or Ultra, Primary Tibia Baseplate |
| 00841690100973 | CR Femoral Cemented, Size 4+ Right |
| 00841690100966 | CR Femoral Cemented, Size 4+ Left |
| 00841690100959 | CR Femoral Cemented, Size 3+ Right |
| 00841690100942 | CR Femoral Cemented, Size 3+ Left |
| 00841690100935 | CR Femoral Cemented, Size 2+ Right |
| 00841690100928 | CR Femoral Cemented, Size 2+ Left |
| 00841690100911 | CR Femoral Cemented, Size 6 Right |
| 00841690100904 | CR Femoral Cemented, Size 6 Left |
| 00841690100898 | CR Femoral Cemented, Size 5 Right |
| 00841690100881 | CR Femoral Cemented, Size 5 Left |
| 00841690100874 | CR Femoral Cemented, Size 4 Right |
| 00841690100867 | CR Femoral Cemented, Size 4 Left |
| 00841690100850 | CR Femoral Cemented, Size 3 Right |
| 00841690100843 | CR Femoral Cemented, Size 3 Left |
| 00841690100836 | CR Femoral Cemented, Size 2 Right |
| 00841690100829 | CR Femoral Cemented, Size 2 Left |
| 00841690100812 | CR Femoral Cemented, Size 1 Right |
| 00841690100805 | CR Femoral Cemented, Size 1 Left |