Omnia Medical TiBrid™-L 13-5L-TR1816-00

GUDID 00843511108724

LATERAL TRIAL, 18x16mm, 0°

OMNIA MEDICAL, LLC

Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 00843511108724
• NIH Device Record Key: a75b63da-90b8-4851-a0b9-d4831d4c88d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnia Medical TiBrid™-L
• Version Model Number: 13-5L-TR1816-00
• Catalog Number: 13-5L-TR1816-00
• 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

Device Dimensions

• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree
• Width: 18 Millimeter
• Height: 16 Millimeter
• Angle: 0 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843511108724 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190363

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

[00843511108724]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-12
• Device Publish Date: 2024-03-04

On-Brand Devices [Omnia Medical TiBrid™-L]

• 00843511105587: LATERAL INTERBODY, 18x50x18mm, 0°
• 00843511105570: LATERAL INTERBODY, 18x50x16mm, 0°
• 00843511105563: LATERAL INTERBODY, 18x50x14mm, 0°
• 00843511105556: LATERAL INTERBODY, 18x50x12mm, 0°
• 00843511105549: LATERAL INTERBODY, 18x50x10mm, 0°
• 00843511105532: LATERAL INTERBODY, 18x50x8mm, 0°
• 00843511105525: LATERAL INTERBODY, 18x45x18mm, 0°
• 00843511105518: LATERAL INTERBODY, 18x45x16mm, 0°
• 00843511105501: LATERAL INTERBODY, 18x45x14mm, 0°
• 00843511105495: LATERAL INTERBODY, 18x45x12mm, 0°
• 00843511105488: LATERAL INTERBODY, 18x45x10mm, 0°
• 00843511105471: LATERAL INTERBODY, 18x45x8mm, 0°
• 00843511105464: LATERAL INTERBODY, 18x40x18mm, 0°
• 00843511105457: LATERAL INTERBODY, 18x40x16mm, 0°
• 00843511105440: LATERAL INTERBODY, 18x40x14mm, 0°
• 00843511105433: LATERAL INTERBODY, 18x40x12mm, 0°
• 00843511105426: LATERAL INTERBODY, 18x40x10mm, 0°
• 00843511105419: LATERAL INTERBODY, 18x40x8mm, 0°
• 00843511105808: LATERAL INTERBODY, 18x45x18mm, 10°
• 00843511105792: LATERAL INTERBODY, 18x45x16mm, 10°
• 00843511105785: LATERAL INTERBODY, 18x45x14mm, 10°
• 00843511105778: LATERAL INTERBODY, 18x45x12mm, 10°
• 00843511105761: LATERAL INTERBODY, 18x45x10mm, 10°
• 00843511105754: LATERAL INTERBODY, 18x40x18mm, 10°
• 00843511105747: LATERAL INTERBODY, 18x40x16mm, 10°
• 00843511105730: LATERAL INTERBODY, 18x40x14mm, 10°
• 00843511105723: LATERAL INTERBODY, 18x40x12mm, 10°
• 00843511105716: LATERAL INTERBODY, 18x40x10mm, 10°
• 00843511105709: LATERAL INTERBODY, 18x60x18mm, 0°
• 00843511105693: LATERAL INTERBODY, 18x60x16mm, 0°
• 00843511105686: LATERAL INTERBODY, 18x60x14mm, 0°
• 00843511105679: LATERAL INTERBODY, 18x60x12mm, 0°
• 00843511105662: LATERAL INTERBODY, 18x60x10mm, 0°
• 00843511105655: LATERAL INTERBODY, 18x60x8mm, 0°
• 00843511105648: LATERAL INTERBODY, 18x55x18mm, 0°
• 00843511105631: LATERAL INTERBODY, 18x55x16mm, 0°
• 00843511105624: LATERAL INTERBODY, 18x55x14mm, 0°
• 00843511105617: LATERAL INTERBODY, 18x55x12mm, 0°
• 00843511105600: LATERAL INTERBODY, 18x55x10mm, 0°
• 00843511105594: LATERAL INTERBODY, 18x55x8mm, 0°
• 00843511106881: LATERAL INTERBODY, 22x55x14mm, 10°
• 00843511106874: LATERAL INTERBODY, 22x55x12mm, 10°
• 00843511106867: LATERAL INTERBODY, 22x55x10mm, 10°
• 00843511106850: LATERAL INTERBODY, 22x50x18mm, 10°
• 00843511106843: LATERAL INTERBODY, 22x50x16mm, 10°
• 00843511106836: LATERAL INTERBODY, 22x50x14mm, 10°
• 00843511106829: LATERAL INTERBODY, 22x50x12mm, 10°
• 00843511106812: LATERAL INTERBODY, 22x50x10mm, 10°
• 00843511106805: LATERAL INTERBODY, 22x45x18mm, 10°
• 00843511106799: LATERAL INTERBODY, 22x45x16mm, 10°