Home GUDID 06975043365987 ISRIE
Primary DI 06975043365987
Brand ISRIE
Company Hansfive (Hangzhou) Dental Technology Co.,Ltd.
Model G3-G1708-19,G3-G1902-25,G3-G1506-25,G3-G2504-25,G3
Device description Nickel Titanium Root Canal File6 psc/packIncluding G3-G1708-19,G3-G1902-25,G3-G1506-25,G3-G2504-25,G3-G2506-25, G3-G3504-25.
Published 2026-01-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name EKS File, Pulp Canal, Endodontic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EKS File, Pulp Canal, Endodontic Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06975043365987 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06975043365987 06975043365987 6975043365987
GMDN Terms# Term, Definition table Term Definition Rotary/reciprocating endodontic file/rasp, single-use A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. 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 a rotary or engine file, or reamer. This is a single-use device.
Sterilization Methods# Method table Method Dry Heat Sterilization
Regulatory Flags# DUNS number 413885255 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices Sharing Product Codes#