APEX CR Knee KC-1102R

GUDID 00841690100836

CR Femoral Cemented, Size 2 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: 00841690100836
• NIH Device Record Key: f6d51000-834a-4bd4-abd6-057bbbb8fd93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APEX CR Knee
• Version Model Number: KC-1102R
• Catalog Number: KC-1102R
• 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	00841690100836 [Primary]

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[00841690100836]

Ethylene Oxide

[00841690100836]

Ethylene Oxide

[00841690100836]

Ethylene Oxide

[00841690100836]

Ethylene Oxide

[00841690100836]

Ethylene Oxide

[00841690100836]

Ethylene Oxide

[00841690100836]

Ethylene Oxide

[00841690100836]

Ethylene Oxide

[00841690100836]

Ethylene Oxide

[00841690100836]

Ethylene Oxide

[00841690100836]

Ethylene Oxide

[00841690100836]

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 CR Knee]

• 00841690111726: Retaining Bolt Congruent or Ultra, Modular Tibia Baseplate
• 00841690104360: CR Femoral Uncemented, Size 6 Right
• 00841690104353: CR Femoral Uncemented, Size 6 Left
• 00841690104322: CR Femoral Uncemented, Size 5 Right
• 00841690104315: CR Femoral Uncemented, Size 5 Left
• 00841690104308: CR Femoral Uncemented, Size 4+ Right
• 00841690104292: CR Femoral Uncemented, Size 4+ Left
• 00841690104285: CR Femoral Uncemented, Size 4 Right
• 00841690104278: CR Femoral Uncemented, Size 4 Left
• 00841690104261: CR Femoral Uncemented, Size 3+ Right
• 00841690104254: CR Femoral Uncemented, Size 3+ Left
• 00841690104247: CR Femoral Uncemented, Size 3 Right
• 00841690104230: CR Femoral Uncemented, Size 3 Left
• 00841690104223: CR Femoral Uncemented, Size 2+ Right
• 00841690104216: CR Femoral Uncemented, Size 2+ Left
• 00841690104209: CR Femoral Uncemented, Size 2 Right
• 00841690104193: CR Femoral Uncemented, Size 2 Left
• 00841690104162: CR Femoral Uncemented, Size 1 Right
• 00841690104155: CR Femoral Uncemented, Size 1 Left
• 00841690104148: CR Femoral Cemented, Size 7 Right
• 00841690104131: CR Femoral Cemented, Size 7 Left
• 00841690102014: Retaining Bolt Congruent or Ultra, Primary Tibia Baseplate
• 00841690100973: CR Femoral Cemented, Size 4+ Right
• 00841690100966: CR Femoral Cemented, Size 4+ Left
• 00841690100959: CR Femoral Cemented, Size 3+ Right
• 00841690100942: CR Femoral Cemented, Size 3+ Left
• 00841690100935: CR Femoral Cemented, Size 2+ Right
• 00841690100928: CR Femoral Cemented, Size 2+ Left
• 00841690100911: CR Femoral Cemented, Size 6 Right
• 00841690100904: CR Femoral Cemented, Size 6 Left
• 00841690100898: CR Femoral Cemented, Size 5 Right
• 00841690100881: CR Femoral Cemented, Size 5 Left
• 00841690100874: CR Femoral Cemented, Size 4 Right
• 00841690100867: CR Femoral Cemented, Size 4 Left
• 00841690100850: CR Femoral Cemented, Size 3 Right
• 00841690100843: CR Femoral Cemented, Size 3 Left
• 00841690100836: CR Femoral Cemented, Size 2 Right
• 00841690100829: CR Femoral Cemented, Size 2 Left
• 00841690100812: CR Femoral Cemented, Size 1 Right
• 00841690100805: CR Femoral Cemented, Size 1 Left