Home GUDID D716GTR08020251 ProFile GT Rotary File
Primary DI D716GTR08020251
Brand ProFile GT Rotary File
Company TULSA DENTAL PRODUCTS LLC
Model GTR0802025
Catalog number GTR0802025
Device description PFile GT: NT .08 020/25mm
Published 2022-07-20
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 D716GTR08020251 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Rotary/reciprocating endodontic file/rasp, reusable 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 reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 942778564 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07630049901858 rootEX instrument short 0,8 mm, pu: 6 Diaswiss SA EKS 2023-10-02 07630049902053 K-Files 21mm 010, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049950856 rootEX instrument short 1,3 mm, pu: 6 Diaswiss SA EKS 2023-10-02 07630049950870 rootEX instrument short 1,8 mm, pu: 6 Diaswiss SA EKS 2023-10-02 07630049950917 rootEX instrument long 0,8 mm, pu: 6 p Diaswiss SA EKS 2023-10-02 07630049950931 rootEX instrument long 1,3 mm, pu: 6 p Diaswiss SA EKS 2023-10-02 07630049950955 rootEX instrument long 1,8 mm, pu: 6 p Diaswiss SA EKS 2023-10-02 07630049952584 rootEX drill short shank 0,8 mm, pu: 6 Diaswiss SA EKS 2023-10-02 07630049952591 rootEX drill short shank 1,1 mm, pu: 6 Diaswiss SA EKS 2023-10-02 07630049986831 K-Files 29mm 008, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986848 K-Files 29mm 010, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986862 K-Files 29mm 015, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986886 K-Files 29mm 020, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986909 K-Files 29mm 025, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986923 K-Files 29mm 030, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986947 K-Files 29mm 035, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986961 K-Files 29mm 040, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986985 K-Files 29mm 045, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987005 K-Files 29mm 050, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987029 K-Files 29mm 055, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987043 K-Files 29mm 060, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987067 K-Files 29mm 070, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987081 K-Files 29mm 080, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987203 Hedstroem files 21mm 055, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987357 Hedstroem files 25mm 055, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987401 Hedstroem files 29mm 008, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987418 Hedstroem files 29mm 010, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987432 Hedstroem files 29mm 015, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987456 Hedstroem files 29mm 020, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987470 Hedstroem files 29mm 025, pu: 6 pcs Diaswiss SA EKS 2023-10-02