NA

Basic Information

• Brand Name: NA
• Primary DI: 00844868017349
• Version / Model: UNITS
• Company Name: BIOMET 3I, LLC
• Labeler DUNS: 186127825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-03-24
• Public Version: 4
• Public Version Date: 2022-03-10
• Public Version Status: Update
• Public Device Record Key: 3f96294b-9294-4dcc-bb86-0eed28e4bdfa

Device Description

UNIVERSAL TRY-IN SCREW SQUARE DRIVE (5 PACK)

Device Characteristics

• Single Use: No
• 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: Yes
• 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
NDP	ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61646	Dental prosthesis/implant abutment screw analog, reusable	A device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Also known as guide pin, it may also be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844868017349	GS1
Unit of Use	30844868017340	GS1

Customer Contacts

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