| Primary Device ID | 00841690101031 |
| NIH Device Record Key | c5476aa2-7816-45f3-8562-de44c02a762b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OMNI Knee |
| Version Model Number | KC-2202R |
| Catalog Number | KC-2202R |
| 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 | 00841690101031 [Primary] |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841690101031]
Ethylene Oxide
[00841690101031]
Ethylene Oxide
[00841690101031]
Ethylene Oxide
[00841690101031]
Ethylene Oxide
[00841690101031]
Ethylene Oxide
[00841690101031]
Ethylene Oxide
[00841690101031]
Ethylene Oxide
[00841690101031]
Ethylene Oxide
[00841690101031]
Ethylene Oxide
[00841690101031]
Ethylene Oxide
[00841690101031]
Ethylene Oxide
[00841690101031]
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 |
| 00841690115472 | Modular Tibia Keel Size 3-4 |
| 00841690111764 | Modular Tibia Pegs |
| 00841690111757 | Modular Tibia Augment Bolt Size 12mm |
| 00841690111740 | Modular Tibia Augment Bolt Size 8mm |
| 00841690111733 | Modular Tibia Augment Bolt Size 4mm |
| 00841690111542 | Modular Tibia Keel Size 5-6 |
| 00841690111535 | Modular Tibia Keel Size 1-2 |
| 00841690111528 | Modular Tibia Cap |
| 00841690111504 | MODULAR TIBIAL BASEPLATE Size 6 |
| 00841690111498 | MODULAR TIBIAL BASEPLATE Size 5 |
| 00841690111481 | MODULAR TIBIAL BASEPLATE Size 4 |
| 00841690111474 | MODULAR TIBIAL BASEPLATE Size 3 |
| 00841690111467 | MODULAR TIBIAL BASEPLATE Size 2 |
| 00841690111450 | MODULAR TIBIAL BASEPLATE Size 1 |
| 00841690104759 | Congruent Tibial Insert, Size 2 x 18mm |
| 00841690104681 | Congruent Tibial Insert, Size 3 x 18mm |
| 00841690104629 | Primary Tibia Baseplate Uncemented with screw holes, size 6 Right |
| 00841690104612 | Primary Tibia Baseplate Uncemented with screw holes, size 6 Left |
| 00841690104605 | Primary Tibia Baseplate Uncemented with screw holes, size 5 Right |
| 00841690104599 | Primary Tibia Baseplate Uncemented with screw holes, size 5 Left |
| 00841690104582 | Primary Tibia Baseplate Uncemented with screw holes, size 4 Right |
| 00841690104575 | Primary Tibia Baseplate Uncemented with screw holes, size 4 Left |
| 00841690104568 | Primary Tibia Baseplate Uncemented with screw holes, size 3 Right |
| 00841690104551 | Primary Tibia Baseplate Uncemented with screw holes, size 3 Left |
| 00841690104544 | Primary Tibia Baseplate Uncemented with screw holes, size 2 Right |
| 00841690104537 | Primary Tibia Baseplate Uncemented with screw holes, size 2 Left |
| 00841690104520 | Primary Tibia Baseplate Uncemented with screw holes, size 1 Right |
| 00841690104513 | Primary Tibia Baseplate Uncemented with screw holes, size 1 Left |
| 00841690104506 | Primary Tibia Baseplate Uncemented, size 6 Right |
| 00841690104490 | Primary Tibia Baseplate Uncemented, size 6 Letf |
| 00841690104483 | Primary Tibia Baseplate Uncemented, size 5 Right |
| 00841690104476 | Primary Tibia Baseplate Uncemented, size 5 Left |
| 00841690104469 | Primary Tibia Baseplate Uncemented, size 4 Right |
| 00841690104452 | Primary Tibia Baseplate Uncemented, size 4 Left |
| 00841690104445 | Primary Tibia Baseplate Uncemented, size 3 Right |
| 00841690104438 | Primary Tibia Baseplate Uncemented, size 3 Left |
| 00841690104421 | Primary Tibia Baseplate Uncemented, size 2 Right |
| 00841690104414 | Primary Tibia Baseplate Uncemented, size 2 Left |
| 00841690104407 | Primary Tibia Baseplate Uncemented, size 1 Right |
| 00841690104391 | Primary Tibia Baseplate Uncemented, size 1 Left |
| 00841690104384 | Primary Tibial Baseplate Cemented, size 7 Right |
| 00841690104377 | Primary Tibial Baseplate Cemented, size 7 Left |
| 00841690103615 | Standard Tibial Insert CR, Size 6 x 14 mm |
| 00841690103608 | Standard Tibial Insert CR, Size 6 x 12 mm |
| 00841690103592 | Standard Tibial Insert CR, Size 6 x 11 mm |
| 00841690103585 | Standard Tibial Insert CR, Size 6 x 10 mm |
| 00841690103578 | Standard Tibial Insert CR, Size 5 x 14 mm |
| 00841690103561 | Standard Tibial Insert CR, Size 5 x 12 mm |
| 00841690103554 | Standard Tibial Insert CR, Size 5 x 11 mm |
| 00841690103547 | Standard Tibial Insert CR, Size 5 x 10 mm |