5.0mm Drill Bit - Non-Cervical

Basic Information

• Brand Name: 5.0mm Drill Bit - Non-Cervical
• Primary DI: 00810131880866
• Version / Model: SR12-6310
• Company Name: SURGENTEC, LLC
• Labeler DUNS: 004095409
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-12
• Public Version: 3
• Public Version Date: 2026-02-18
• Public Version Status: Update
• Public Device Record Key: 69f838fc-bb5f-4487-b69a-3f94cef0ac2d

Device Description

SR12- ION Facet Screw System

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: Yes
• 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
MRW	System, Facet Screw Spinal Device	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
60792	Facet joint prosthesis	A sterile implantable device intended to resurface and/or replace a degenerative or otherwise diseased vertebral facet (apophyseal, zygapophyseal) joint. It typically consists of small plate-like metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr)] device intended to be fixed to the superior and inferior articulating surfaces of the joint. Fixation may be by means of a trans-laminar or trans-facet screw or bolt.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810131880866	GS1