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.

• 00841690110446 - APEX Knee System: 2024-09-11 Tibial Insert Trial Forceps
• 00841690110491 - APEX Knee System: 2024-09-11 pin puller
• 00841690184072 - APEX Knee System: 2024-09-11 Femoral Impactor
• 00841690184751 - K1 Hip Syetem: 2024-09-11Unity Chamfer Block Impactor
• 00841690184751 - K1 Hip Syetem: 2024-09-11 Unity Chamfer Block Impactor
• 00841690184867 - Trinity System: 2024-09-11 Shell Impactor Assembly
• 00841690184966 - TriFit CF Hip System: 2024-09-11 Corin TriFit Stem Introducer w rounded tip
• 00841690186687 - APEX Knee System: 2024-09-11 Tibial Component Extractor
• 00841690186694 - APEX Knee System: 2024-09-11 Femoral Component Extractor