BioHorizons

Basic Information

• Brand Name: BioHorizons
• Primary DI: 00847236010225
• Version / Model: 400-240
• Company Name: BIOHORIZONS IMPLANT SYSTEMS, INC
• Labeler DUNS: 967279910
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-21
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 0c956452-4247-4f4f-b9ce-840c84fcc431

Device Description

AutoTac Titanium Tack Vial, pkg of 5

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
DZL	Screw, Fixation, Intraosseous	Dental	872.4880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46645	Dental regeneration membrane fixation tack, non-bioabsorbable	A non-bioabsorbable tack intended to be driven into bone to fix or stabilize bioabsorbable barrier membranes used for the regeneration of tissue and/or bone in the oral cavity, or used for other clinical situations that require membrane utilization. The device is typically made of metal (e.g., titanium alloy). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847236010225	GS1

Premarket Submissions

Submission Number	Supplement Number
K022790	000