DOMINION

Basic Information

• Brand Name: DOMINION
• Primary DI: 00840085271090
• Version / Model: TBEA14120
• Catalog Number: TBEA14120
• Company Name: Astura Medical
• Labeler DUNS: 073029645
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-22
• Public Version: 3
• Public Version Date: 2025-12-10
• Public Version Status: Update
• Public Device Record Key: 2dcf309f-a084-458e-a090-abad4dc50242

Device Description

VARIABLE LORDOSIS FIXATED ZERO ENDPLATE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65426	Cervical intervertebral disc prosthesis endplate	An implantable, disc-like component of a modular cervical total intervertebral disc prosthesis designed to be used in pairs for attachment to the prepared vertebrae above and below the excised natural disc, and within which is positioned the core component (not included) of the prosthesis, to replace a dysfunctional intervertebral disc in the cervical spine; it is not the complete prosthesis assembly. It typically has a serrated surface, or flange, to facilitate attachment to the vertebrae and is made of metallic materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840085271090	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Depth	16	Millimeter
Length	14	Millimeter
Outer Diameter	12	Millimeter