Primary Device ID | 00841690113652 |
NIH Device Record Key | 2d02fb57-a07d-474e-ad47-3063f7ca579f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | APEX PS Knee |
Version Model Number | KP-22412 |
Catalog Number | KP-22412 |
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 | 00841690113652 [Primary] |
MBH | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00841690113652]
Ethylene Oxide
[00841690113652]
Ethylene Oxide
[00841690113652]
Ethylene Oxide
[00841690113652]
Ethylene Oxide
[00841690113652]
Ethylene Oxide
[00841690113652]
Ethylene Oxide
[00841690113652]
Ethylene Oxide
[00841690113652]
Ethylene Oxide
[00841690113652]
Ethylene Oxide
[00841690113652]
Ethylene Oxide
[00841690113652]
Ethylene Oxide
[00841690113652]
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 |
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 |