APEX Knee System KC-2803L

GUDID 00841690132837

Primary Tibial Baseplate Cemented, Pegged, size 3 Left

Omni Life Science, Inc.

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• Primary Device ID: 00841690132837
• NIH Device Record Key: e85e884c-9f9e-45e1-aa81-48869477bbb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APEX Knee System
• Version Model Number: KC-2803L
• Catalog Number: KC-2803L
• Company DUNS: 061339651
• Company Name: Omni Life 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
• 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	00841690132837 [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

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

[00841690132837]

Ethylene Oxide;Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-01
• Device Publish Date: 2021-09-23

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• 00841690131762: High Performance Revision Femur, Size 4+ Left, Cemented
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• 00841690131724: High Performance Revision Femur, Size 3+ Left, Cemented
• 00841690131694: High Performance Revision Femur, Size 2+ Right, Cemented
• 00841690131687: High Performance Revision Femur, Size 2+ Left, Cemented
• 00841690131656: High Performance Revision Femur, Size 1+ Right, Cemented
• 00841690131649: High Performance Revision Femur, Size 1+ Left, Cemented
• 00841690131632: High Performance Revision Femur, Size 1 Right, Cemented
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• 00841690134336: PS-R Insert, Size 5 x 28mm
• 00841690134329: PS-R Insert, Size 5 x 24mm
• 00841690134312: PS-R Insert, Size 5 x 20mm
• 00841690134305: PS-R Insert, Size 5 x 18mm
• 00841690134299: PS-R Insert, Size 5 x 16mm
• 00841690134282: PS-R Insert, Size 5 x 14mm
• 00841690134275: PS-R Insert, Size 5 x 12mm
• 00841690134268: PS-R Insert, Size 5 x 11mm
• 00841690134251: PS-R Insert, Size 5 x 10mm
• 00841690134244: PS-R Insert, Size 4 x 28mm
• 00841690134213: PS-R Insert, Size 4 x 18mm
• 00841690134190: PS-R Insert, Size 4 x 14mm
• 00841690132905: Primary Tibial Baseplate Cemented, Pegged, size 6 Right
• 00841690132899: Primary Tibial Baseplate Cemented, Pegged, size 6 Left
• 00841690132882: Primary Tibial Baseplate Cemented, Pegged, size 5 Right
• 00841690132875: Primary Tibial Baseplate Cemented, Pegged, size 5 Left
• 00841690132868: Primary Tibial Baseplate Cemented, Pegged, size 4 Right
• 00841690132851: Primary Tibial Baseplate Cemented, Pegged, size 4 Left
• 00841690132844: Primary Tibial Baseplate Cemented, Pegged, size 3 Right
• 00841690132837: Primary Tibial Baseplate Cemented, Pegged, size 3 Left
• 00841690132820: Primary Tibial Baseplate Cemented, Pegged, size 2 Right
• 00841690132813: Primary Tibial Baseplate Cemented, Pegged, size 2 Left
• 00841690132806: Primary Tibial Baseplate Cemented, Pegged, size 1 Right
• 00841690132790: Primary Tibial Baseplate Cemented, Pegged, size 1 Left
• 00841690131977: Congruent Tibial Insert, Size 1 x 12mm
• 00841690131960: Congruent Tibial Insert, Size 1 x 11mm
• 00841690131953: Congruent Tibial Insert, Size 1 x 10mm
• 00841690131908: Patella 35 mm x 10 mm
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• 00841690131366: High Performance PS Femoral Component, Size 6+ Left, Cemented
• 00841690131359: High Performance PS Femoral Component, Size 6 Right, Cemented
• 00841690131342: High Performance PS Femoral Component, Size 6 Left, Cemented
• 00841690131335: High Performance PS Femoral Component, Size 5+ Right, Cemented
• 00841690131328: High Performance PS Femoral Component, Size 5+ Left, Cemented
• 00841690131311: High Performance PS Femoral Component, Size 5 Right, Cemented
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