H-FILES

Basic Information

• Brand Name: H-FILES
• Primary DI: 07640142415213
• Version / Model: 01.153.25.045.CG
• Catalog Number: 01.153.25.045.CG
• Company Name: FKG Dentaire Sàrl
• Labeler DUNS: 482884061
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-14
• Public Version: 1
• Public Version Date: 2022-08-22
• Public Version Status: New
• Public Device Record Key: a84f92bf-7583-42a0-a914-0c6ec4707d51

Device Description

H-Files 153, 25 mm, # 45, handle SMG

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EKS	File, Pulp Canal, Endodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31878	Manual endodontic file/rasp, reusable	A hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640142415213	GS1