APEX Knee System KR-50155

GUDID 00841690117520

Distal Reamer (Hudson)

Omni Life Science, Inc.

Bone-resection orthopaedic reamer, reusable

• Primary Device ID: 00841690117520
• NIH Device Record Key: e171ece2-05fe-4fc0-89ad-dcc30afb640a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APEX Knee System
• Version Model Number: KR-50155
• Catalog Number: KR-50155
• Company DUNS: 061339651
• Company Name: Omni Life Science, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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
• 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	00841690117520 [Primary]

FDA Product Code

• HTO: REAMER

Sterilization

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

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

[00841690117520]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-13
• Device Publish Date: 2023-01-10

On-Brand Devices [APEX Knee System]

• 00841690131816: High Performance Revision Femur, Size 5+ Right, Cemented
• 00841690131809: High Performance Revision Femur, Size 5+ Left, Cemented
• 00841690131779: High Performance Revision Femur, Size 4+ Right, Cemented
• 00841690131762: High Performance Revision Femur, Size 4+ Left, Cemented
• 00841690131731: High Performance Revision Femur, Size 3+ Right, Cemented
• 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
• 00841690131625: High Performance Revision Femur, Size 1 Left, Cemented
• 00841690129653: PS femur, uncemented Size 5+ Left
• 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
• 00841690131373: High Performance PS Femoral Component, Size 6+ Right, Cemented
• 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
• 00841690131304: High Performance PS Femoral Component, Size 5 Left, Cemented
• 00841690131298: High Performance PS Femoral Component, Size 4+ Right, Cemented