3M™ Unitek™

Basic Information

• Brand Name: 3M™ Unitek™
• Primary DI: 00652221236562
• Version / Model: 804-175
• Catalog Number: 804-175
• Company Name: 3M UNITEK CORPORATION
• Labeler DUNS: 008256356
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 2
• Public Version Date: 2019-02-12
• Public Version Status: Update
• Public Device Record Key: 005e0bf5-de4d-4bab-b639-0c5b8c4bd1aa

Device Description

3M (TM) UNITEK (TM) DEBONDING INSTRUMENT FOR ULTRA SL SYSTEM

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JEX	PLIER, ORTHODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33209	Orthodontic pliers	A hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00652221236562	GS1

Customer Contacts

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