Home GUDID J015201040141 ENGINE REAMERS
Primary DI J015201040141
Brand ENGINE REAMERS
Company MICRO MEGA
Model n020 L25
Catalog number 20104014
Device description Endodontic instruments for professionnal use only
Published 2020-08-28
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name EKP Reamer, Pulp Canal, Endodontic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EKP Reamer, Pulp Canal, Endodontic Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status J015201040149 Package HIBCC 10 Not in Commercial Distribution J015201040141 Primary HIBCC 0 J015201040140 Unit of Use 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 276075371 Device count 6 DM exempt true Premarket exempt true Lot or batch true Serial number 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 07630049902770 Reamer 21mm 055, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990104 Reamer 29mm 008, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990128 Reamer 29mm 010, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990142 Reamer 29mm 015, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990166 Reamer 29mm 020, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990180 Reamer 29mm 025, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990203 Reamer 29mm 030, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990227 Reamer 29mm 035, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990241 Reamer 29mm 040, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990265 Reamer 29mm 045, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990289 Reamer 29mm 050, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990302 Reamer 29mm 055, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990326 Reamer 29mm 060, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990340 Reamer 29mm 070, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049990364 Reamer 29mm 080, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996595 Reamer 21mm 008, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996601 Reamer 21mm 010, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996618 Reamer 21mm 015, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996625 Reamer 21mm 020, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996632 Reamer 21mm 025, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996649 Reamer 21mm 030, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996656 Reamer 21mm 035, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996663 Reamer 21mm 040, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996670 Reamer 21mm 045, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996687 Reamer 21mm 050, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996694 Reamer 21mm 055, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996700 Reamer 21mm 060, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996717 Reamer 21mm 070, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996724 Reamer 21mm 080, pu: 6 pcs Diaswiss SA EKP 2023-10-02 07630049996731 Reamer 25mm 008, pu: 6 pcs Diaswiss SA EKP 2023-10-02