HU-FRIEDY

Basic Information

• Brand Name: HU-FRIEDY
• Primary DI: 10889950004316
• Version / Model: AF31/32
• Catalog Number: AF31/32
• Company Name: HU-FRIEDY MFG. CO., LLC
• Labeler DUNS: 005085972
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-12
• Public Version: 1
• Public Version Date: 2020-11-20
• Public Version Status: New
• Public Device Record Key: 7a4d22d0-153f-47a3-a95e-25b6feb8cce2

Device Description

#31/32 Rhein DE Amalgam File

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
EKA	FILE, MARGIN FINISHING, OPERATIVE	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35793	Dental restoration carver, amalgam, reusable	A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889950004316	GS1

Customer Contacts

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