Home GUDID 10819514029912 EdgeTaper
Primary DI 10819514029912
Brand EdgeTaper
Company US ENDODONTICS, LLC
Model SETF321
Catalog number SETF321
Device description Sterile Endodontic Rotary Files
Published 2023-02-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
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 00819514029915 Primary GS1 0 10819514029912 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00819514029915 00819514029915 819514029915 0819514029915 10819514029912 10819514029912
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 Radiation Sterilization
Regulatory Flags# DUNS number 061317427 Device count 6 DM exempt true Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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
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