TiBrid-SA

GUDID 00843511122065

60 Degree Flex Tube Driver

OMNIA MEDICAL, LLC

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

• Primary Device ID: 00843511122065
• NIH Device Record Key: 11437e70-2f96-4465-b740-a7bb0f2a59ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiBrid-SA
• Version Model Number: 17-5A-DV60
• Company DUNS: 079467378
• Company Name: OMNIA MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843511122065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203207

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

[00843511122065]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-22
• Device Publish Date: 2023-05-12

On-Brand Devices [TiBrid-SA]

• 00843511122294: Awl, 60 Degrees
• 00843511122287: Awl, 45 Degrees
• 00843511122096: 60 Degree Flex Tube Drill
• 00843511122089: 45 Degree Flex Tube Drill
• 00843511122072: 30 Degree Flex Tube Drill
• 00843511122065: 60 Degree Flex Tube Driver
• 00843511122058: 45 Degree Flex Tube Driver
• 00843511122041: 30 Degree Flex Tube Driver
• 00843511121853: TiBrid-SA Instrument Tray
• 00843511121846: TiBrid-SA Instrument Tray
• 00843511121839: TiBrid-SA Instrument Tray
• 00843511113162: Screw Remover
• 00843511113100: Screwdriver, Tapered, T20 TiN
• 00843511113087: Screwdriver, Flex, Tapered, T20
• 00843511113070: Screwdriver, Tapered, T20
• 00843511113063: Screwdriver, Straight, T20
• 00843511113056: Awl, 30 Degrees (Flex)
• 00843511113049: Awl, Punch
• 00843511113032: Awl, Straight
• 00843511113018: Interbody Drill Guide, Fixed
• 00843511113001: Drill, Flex
• 00843511112998: Drill, Straight
• 00843511112974: Interbody Inserter, 45°
• 00843511112967: Interbody Inserter, Straight
• 00843511112660: TiBrid-SA Screw Cap Caddy
• 00843511112653: TiBrid-SA Self-Tapping Fixed Screw, 15 to 35mm length, Caddy
• 00843511112646: TiBrid-SA Self-Tapping Variable Screw, 15 to 35mm length, Caddy
• 00843511112639: TiBrid-SA Self-Drilling Fixed Screw, 15 to 35mm length, Caddy
• 00843511112622: TiBrid-SA Self-Drilling Variable Screw, 15 to 35mm length, Caddy
• 00843511112615: TiBrid™-SA Plate Caddy