Omnia Medical TiBrid™- A/SA

GUDID 00843511123109

TiBrid™-SA Bullet Trial, 10mm

OMNIA MEDICAL, LLC

Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 00843511123109
• NIH Device Record Key: 9c0766b6-fc73-4d1d-80ab-bb94f5e995b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnia Medical TiBrid™- A/SA
• Version Model Number: 17-5A-BT10
• Company DUNS: 079467378
• Company Name: OMNIA MEDICAL, LLC
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com

Device Dimensions

• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843511123109 [Primary]

FDA Product Code

• GCZ: Retainer, Surgical

Sterilization

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

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

[00843511123109]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-26
• Device Publish Date: 2023-10-18

On-Brand Devices [Omnia Medical TiBrid™- A/SA ]

• 00843511123154: Bullet Trial Inserter
• 00843511123147: TiBrid™-SA Bullet Trial, 14mm
• 00843511123130: TiBrid™-SA Bullet Trial, 13mm
• 00843511123123: TiBrid™-SA Bullet Trial, 12mm
• 00843511123116: TiBrid™-SA Bullet Trial, 11mm
• 00843511123109: TiBrid™-SA Bullet Trial, 10mm
• 00843511123093: TiBrid™-SA Bullet Trial, 9mm
• 00843511123086: TiBrid™-SA Bullet Trial, 8mm
• 00843511123079: Omnia Medical TiBrid-A Trial Caddy 40mm
• 00843511123062: Omnia Medical TiBrid-A Trial Caddy 36mm
• 00843511123055: Omnia Medical TiBrid-A Trial Caddy 32mm
• 00843511123048: Omnia Medical TiBrid-A Rasp Caddy 40mm
• 00843511123031: Omnia Medical TiBrid-A Rasp Caddy 36mm
• 00843511123024: Omnia Medical TiBrid-A Rasp Caddy 32mm
• 00843511128241: Angled ALIF Spreader
• 00843511128180: ALIF Spreader