K1 Hip Syetem CK-07100

GUDID 00841690184751

Unity Chamfer Block Impactor

Omni Life Science, Inc.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 00841690184751
• NIH Device Record Key: bac7fc7a-ba02-4d67-b0d1-83eee14e1aa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K1 Hip Syetem
• Version Model Number: CK-07100
• Catalog Number: CK-07100
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841690184751 [Primary]

FDA Product Code

• HWA: IMPACTOR

Sterilization

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

[00841690184751]

Moist Heat or Steam Sterilization

[00841690184751]

Moist Heat or Steam Sterilization

[00841690184751]

Moist Heat or Steam Sterilization

[00841690184751]

Moist Heat or Steam Sterilization

[00841690184751]

Moist Heat or Steam Sterilization

[00841690184751]

Moist Heat or Steam Sterilization

[00841690184751]

Moist Heat or Steam Sterilization

[00841690184751]

Moist Heat or Steam Sterilization

[00841690184751]

Moist Heat or Steam Sterilization

[00841690184751]

Moist Heat or Steam Sterilization

[00841690184751]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-11
• Device Publish Date: 2023-01-10

Devices Manufactured by Omni Life Science, Inc.

• 00841690110118 - APEX Knee System: 2026-02-09 Femoral inserter
• 00841690110125 - APEX Knee System: 2026-02-09 Femoral Impactor Pad
• 00841690110286 - APEX Knee System: 2026-02-09 Tibial Tray Impactor Pad
• 00841690110460 - APEX Knee System: 2026-02-09 Universal Handle
• 00841690110484 - APEX Knee System: 2026-02-09 Knee Impactor Handle
• 00841690110545 - APEX Knee System: 2026-02-09 slap hammer
• 00841690117940 - APEX Knee System: 2026-02-09 Modular Tibia Inserter
• 00841690119753 - APEX Knee System: 2026-02-09 TIBIAL BASEPLATE/INSERT IMPACTOR