| Primary Device ID | 00841690184683 |
| NIH Device Record Key | aa2c863c-a2bb-497d-97a8-5fbf1e8d62dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Unity Knee System |
| Version Model Number | CK-07192 |
| Catalog Number | CK-07192 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841690184683 [Primary] |
| HWA | IMPACTOR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841690184683]
Moist Heat or Steam Sterilization
[00841690184683]
Moist Heat or Steam Sterilization
[00841690184683]
Moist Heat or Steam Sterilization
[00841690184683]
Moist Heat or Steam Sterilization
[00841690184683]
Moist Heat or Steam Sterilization
[00841690184683]
Moist Heat or Steam Sterilization
[00841690184683]
Moist Heat or Steam Sterilization
[00841690184683]
Moist Heat or Steam Sterilization
[00841690184683]
Moist Heat or Steam Sterilization
[00841690184683]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2026-02-09 |
| Device Publish Date | 2023-01-10 |
| 00841690185284 | Unity Patella Trial Size 1 |
| 00841690185277 | Unity Patella Trial Size 2 |
| 00841690185260 | Unity Patella Trial Size 3 |
| 00841690185253 | Unity Patella Trial Size 4 |
| 00841690185246 | Unity Patella Trial Size 5 |
| 00841690185239 | Unity Sizer, 3 deg |
| 00841690184669 | Unity Knee Tibial Implant Introducer |
| 00841690184652 | 4 in 1 Block Drop in Handle |
| 00841690184683 | Unity Femoral Inserter |