HU-FRIEDY

Basic Information

• Brand Name: HU-FRIEDY
• Primary DI: 10889950014834
• Version / Model: M8H
• Catalog Number: M8H
• Company Name: HU-FRIEDY MFG. CO., LLC
• Labeler DUNS: 005085972
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-12
• Public Version: 4
• Public Version Date: 2022-01-20
• Public Version Status: Update
• Public Device Record Key: bfdaff67-ca19-4f4e-bd57-4be353b56e44
• Distribution End Date: 2022-01-19

Device Description

2in- Exam Mirror w/Handle

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
EAX	MIRROR, MOUTH	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31776	Dental mirror, reusable	A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889950014834	GS1

Customer Contacts

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