3M™ Unitek™

Basic Information

• Brand Name: 3M™ Unitek™
• Primary DI: 00652221153494
• Version / Model: 532-332
• Catalog Number: 532-332
• Company Name: 3M UNITEK CORPORATION
• Labeler DUNS: 008256356
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: 5ca8df19-12ba-40ca-8d07-f6c58dfb5b04

Device Description

3M™ Unitek™ Crimpable Auxiliary Spiral Hook, 532-332, .022, Right, 10/Pk

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: 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
ECN	CLAMP, WIRE, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35439	Orthodontic clasp, metal, preformed	A prefabricated dental device made of wrought metal alloy intended to retain and stabilize a removable orthodontic appliance to stationary teeth. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	80652221153490	GS1
Primary	00652221153494	GS1

Customer Contacts

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