| Primary Device ID | 00841690115229 |
| NIH Device Record Key | bfe6f5fc-1c0b-4e3a-8b69-69afb2cf6bfa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APEX Revision Knee |
| Version Model Number | KP-37005 |
| Catalog Number | KP-37005 |
| 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 | 00841690115229 [Primary] |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841690115229]
Ethylene Oxide
[00841690115229]
Ethylene Oxide
[00841690115229]
Ethylene Oxide
[00841690115229]
Ethylene Oxide
[00841690115229]
Ethylene Oxide
[00841690115229]
Ethylene Oxide
[00841690115229]
Ethylene Oxide
[00841690115229]
Ethylene Oxide
[00841690115229]
Ethylene Oxide
[00841690115229]
Ethylene Oxide
[00841690115229]
Ethylene Oxide
[00841690115229]
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 |
| 00841690126355 | Femoral Augment Distal, Size 5+ Right, 10mm |
| 00841690126348 | Femoral Augment Distal, Size 5+ Left, 10mm |
| 00841690126331 | Femoral Augment Posterior, Size 5+, 10mm |
| 00841690126324 | Femoral Augment Distal, Size 5+ Right, 5mm |
| 00841690126317 | Femoral Augment Distal, Size 5+ Left, 5mm |
| 00841690126300 | Femoral Augment Posterior, Size 5+, 5mm |
| 00841690125204 | Femoral Augment Distal, Size 4+ Right, 10mm |
| 00841690125198 | Femoral Augment Distal, Size 4+ Left, 10mm |
| 00841690125181 | Femoral Augment Posterior, Size 4+, 10mm |
| 00841690125174 | Femoral Augment Distal, Size 4+ Right, 5mm |
| 00841690125167 | Femoral Augment Distal, Size 4+ Left, 5mm |
| 00841690125150 | Femoral Augment Posterior, Size 4+, 5mm |
| 00841690124795 | Modular Stem 17mm x 125mm |
| 00841690124788 | Modular Stem 15mm x 125mm |
| 00841690124771 | Modular Stem 13mm x 125mm |
| 00841690124764 | Modular Stem 11mm x 125mm |
| 00841690124757 | Modular Stem 9mm x 125mm |
| 00841690124726 | Modular Offset Stem 9mm x 75mm x 4mm |
| 00841690124719 | Modular Offset Stem 9mm x 75mm x 2mm |
| 00841690124702 | Modular Offset Stem 9mm x 150mm x 4mm |
| 00841690124696 | Modular Offset Stem 9mm x 150mm x 2mm |
| 00841690124689 | Modular Offset Stem 9mm x 125mm 4mm |
| 00841690124672 | Modular Offset Stem 9mm x 125mm 2mm |
| 00841690124665 | Modular Offset Stem 9mm x 100mm x 4mm |
| 00841690124658 | Modular Offset Stem 9mm x 100mm x 2mm |
| 00841690124641 | Modular Offset Stem 17mm x 75mm x 4mm |
| 00841690124634 | Modular Offset Stem 17mm x 75mm x 2mm |
| 00841690124627 | Modular Offset Stem 17mm x 150mm x 4mm |
| 00841690124610 | Modular Offset Stem 17mm x 150mm x 2mm |
| 00841690124603 | Modular Offset Stem 17mm x 125mm 4mm |
| 00841690124597 | Modular Offset Stem 17mm x 125mm 2mm |
| 00841690124580 | Modular Offset Stem 17mm x 100mm x 4mm |
| 00841690124573 | Modular Offset Stem 17mm x 100mm x 2mm |
| 00841690124474 | Modular Offset Stem 15mm x 75mm x 4mm |
| 00841690124467 | Modular Offset Stem 15mm x 75mm x 2mm |
| 00841690124450 | Modular Offset Stem 15mm x 150mm x 4mm |
| 00841690124443 | Modular Offset Stem 15mm x 150mm x 2mm |
| 00841690124436 | Modular Offset Stem 15mm x 125mm 4mm |
| 00841690124429 | Modular Offset Stem 15mm x 125mm 2mm |
| 00841690124412 | Modular Offset Stem 15mm x 100mm x 4mm |
| 00841690124405 | Modular Offset Stem 15mm x 100mm x 2mm |
| 00841690124313 | Modular Offset Stem 13mm x 75mm x 4mm |
| 00841690124306 | Modular Offset Stem 13mm x 75mm x 2mm |
| 00841690124290 | Modular Offset Stem 13mm x 150mm x 4mm |
| 00841690124283 | Modular Offset Stem 13mm x 150mm x 2mm |
| 00841690124276 | Modular Offset Stem 13mm x 125mm 4mm |
| 00841690124269 | Modular Offset Stem 13mm x 125mm 2mm |
| 00841690124252 | Modular Offset Stem 13mm x 100mm x 4mm |
| 00841690124245 | Modular Offset Stem 13mm x 100mm x 2mm |
| 00841690124153 | Modular Offset Stem 11mm x 75mm x 4mm |