TiBrid-SA

GUDID 00843511112646

TiBrid-SA Self-Tapping Variable Screw, 15 to 35mm length, Caddy

OMNIA MEDICAL, LLC

Device sterilization/disinfection container, reusable

• Primary Device ID: 00843511112646
• NIH Device Record Key: b74d174b-61a4-4df6-9812-c698d37af231
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiBrid-SA
• Version Model Number: 17-8A-CAD3
• 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	00843511112646 [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

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

Moist Heat or Steam Sterilization

[00843511112646]

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
• 00843511113094: Screwdriver, Straight, T15
• 00843511113025: Plate Drill Guide, Fixed
• 00843511112981: Plate Inserter
• 00843511112585: TiBrid-SA Half Moon Inserter (Custom)
• 00843511113148: Extended Tip Awl
• 00843511128357: TiBrid SA Straight Punch Awl, Extended
• 00843511128333: TiBrid SA Driver, S Inserter
• 00843511128326: TiBrid-SA Tack Inserter Driver