| Primary Device ID | 00841690112068 |
| NIH Device Record Key | 31b0eb75-8e5c-4e90-9271-33ea8ccd4bb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APEX PS Knee |
| Version Model Number | KP-0030L |
| Catalog Number | KP-0030L |
| 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 | 00841690112068 [Primary] |
| MBH | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841690112068]
Ethylene Oxide
[00841690112068]
Ethylene Oxide
[00841690112068]
Ethylene Oxide
[00841690112068]
Ethylene Oxide
[00841690112068]
Ethylene Oxide
[00841690112068]
Ethylene Oxide
[00841690112068]
Ethylene Oxide
[00841690112068]
Ethylene Oxide
[00841690112068]
Ethylene Oxide
[00841690112068]
Ethylene Oxide
[00841690112068]
Ethylene Oxide
[00841690112068]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2015-11-27 |
| 00841690115434 | Retaining Bolt PS or PS-C Insert, Modular Tibia Size 20mm |
| 00841690115427 | Retaining Bolt PS or PS-C Insert, Modular Tibia Size 18mm |
| 00841690115410 | Retaining Bolt PS or PS-C Insert, Modular Tibia Size 16mm |
| 00841690115403 | Retaining Bolt PS or PS-C Insert, Modular Tibia Size 14mm |
| 00841690115397 | Retaining Bolt PS or PS-C Insert, Modular Tibia Size 12mm |
| 00841690115380 | Retaining Bolt PS or PS-C Insert, Modular Tibia Size 11mm |
| 00841690115373 | Retaining Bolt PS or PS-C Insert, Modular Tibia Size 10mm |
| 00841690113836 | PS-C Insert, Size 6 x 20mm |
| 00841690113829 | PS-C Insert, Size 6 x 18mm |
| 00841690113812 | PS-C Insert, Size 6 x 16mm |
| 00841690113805 | PS-C Insert, Size 6 x 14mm |
| 00841690113799 | PS-C Insert, Size 6 x 12mm |
| 00841690113782 | PS-C Insert, Size 6 x 11mm |
| 00841690113775 | PS-C Insert, Size 6 x 10mm |
| 00841690113768 | PS-C Insert, Size 5 x 20mm |
| 00841690113751 | PS-C Insert, Size 5 x 18mm |
| 00841690113744 | PS-C Insert, Size 5 x 16mm |
| 00841690113737 | PS-C Insert, Size 5 x 14mm |
| 00841690113720 | PS-C Insert, Size 5 x 12mm |
| 00841690113713 | PS-C Insert, Size 5 x 11mm |
| 00841690113706 | PS-C Insert, Size 5 x 10mm |
| 00841690113690 | PS-C Insert, Size 4 x 20mm |
| 00841690113683 | PS-C Insert, Size 4 x 18mm |
| 00841690113676 | PS-C Insert, Size 4 x 16mm |
| 00841690113669 | PS-C Insert, Size 4 x 14mm |
| 00841690113652 | PS-C Insert, Size 4 x 12mm |
| 00841690113645 | PS-C Insert, Size 4 x 11mm |
| 00841690113638 | PS-C Insert, Size 4 x 10mm |
| 00841690113621 | PS-C Insert, Size 3 x 20mm |
| 00841690113614 | PS-C Insert, Size 3 x 18mm |
| 00841690113607 | PS-C Insert, Size 3 x 16mm |
| 00841690113591 | PS-C Insert, Size 3 x 14mm |
| 00841690113584 | PS-C Insert, Size 3 x 12mm |
| 00841690113577 | PS-C Insert, Size 3 x 11mm |
| 00841690113560 | PS-C Insert, Size 3 x 10mm |
| 00841690113553 | PS-C Insert, Size 2 x 20mm |
| 00841690113546 | PS-C Insert, Size 2 x 18mm |
| 00841690113539 | PS-C Insert, Size 2 x 16mm |
| 00841690113522 | PS-C Insert, Size 2 x 14mm |
| 00841690113515 | PS-C Insert, Size 2 x 12mm |
| 00841690113508 | PS-C Insert, Size 2 x 11mm |
| 00841690113492 | PS-C Insert, Size 2 x 10mm |
| 00841690113485 | PS-C Insert, Size 1 x 20mm |
| 00841690113478 | PS-C Insert, Size 1 x 18mm |
| 00841690113461 | PS-C Insert, Size 1 x 16mm |
| 00841690113454 | PS-C Insert, Size 1 x 14mm |
| 00841690113447 | PS-C Insert, Size 1 x 12mm |
| 00841690113430 | PS-C Insert, Size 1 x 11mm |
| 00841690113423 | PS-C Insert, Size 1 x 10mm |
| 00841690113416 | PS Insert, Size 6 x 20mm |