APEX PS Knee KP-0045R

GUDID 00841690112136

PS femur, cemented Size 4+ Right

Omnilife Science, Inc

Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic

• Primary Device ID: 00841690112136
• NIH Device Record Key: f393c442-6077-4e3c-b803-36f610586799
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APEX PS Knee
• Version Model Number: KP-0045R
• Catalog Number: KP-0045R
• 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

Customer Support Contacts

• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841690112136 [Primary]

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00841690112136]

Ethylene Oxide

[00841690112136]

Ethylene Oxide

[00841690112136]

Ethylene Oxide

[00841690112136]

Ethylene Oxide

[00841690112136]

Ethylene Oxide

[00841690112136]

Ethylene Oxide

[00841690112136]

Ethylene Oxide

[00841690112136]

Ethylene Oxide

[00841690112136]

Ethylene Oxide

[00841690112136]

Ethylene Oxide

[00841690112136]

Ethylene Oxide

[00841690112136]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-11-27

On-Brand Devices [APEX PS Knee]

• 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