Trinity System CH-07198

GUDID 00841690184867

Shell Impactor Assembly

Omni Life Science, Inc.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 00841690184867
• NIH Device Record Key: f2b725b5-de4d-4b26-bcb5-816b930d0d6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinity System
• Version Model Number: CH-07198
• Catalog Number: CH-07198
• 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	00841690184867 [Primary]

FDA Product Code

• HWA: IMPACTOR

Sterilization

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

[00841690184867]

Moist Heat or Steam Sterilization

[00841690184867]

Moist Heat or Steam Sterilization

[00841690184867]

Moist Heat or Steam Sterilization

[00841690184867]

Moist Heat or Steam Sterilization

[00841690184867]

Moist Heat or Steam Sterilization

[00841690184867]

Moist Heat or Steam Sterilization

[00841690184867]

Moist Heat or Steam Sterilization

[00841690184867]

Moist Heat or Steam Sterilization

[00841690184867]

Moist Heat or Steam Sterilization

[00841690184867]

Moist Heat or Steam Sterilization

[00841690184867]

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

On-Brand Devices [Trinity System]

• 00841690184911: ACETABULAR ALIGNMENT GUIDE
• 00841690184843: Shell Impactor w Proximal Thread Locking
• 00841690184829: Trinity Liner Trials, NEUTRAL, T1 x 28 ID
• 00841690184812: Trinity Liner Trials, NEUTRAL, T2 x 32 ID
• 00841690184805: Trinity Liner Trials, NEUTRAL, T3 x 36 ID
• 00841690184799: Trinity Liner Trials, NEUTRAL, T4 x 36 ID
• 00841690184782: Trinity Liner Trials, NEUTRAL, T4 x 40 ID
• 00841690184775: Trinity Liner Trials, NEUTRAL, T5 x 36 ID
• 00841690184768: Trinity Liner Trials, NEUTRAL, T5 x 40 ID
• 00841690184867: Shell Impactor Assembly