Home GUDID J015600296809 K-Reamers
Primary DI J015600296809
Brand K-Reamers
Company MICRO MEGA
Model N040 L31
Catalog number 60029680
Device description Endodontic instrument for professional dental use only
Published 2020-12-21
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 false 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 J015600296809 Package HIBCC 10 In Commercial Distribution J015600296801 Primary HIBCC 0 J015600296800 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from sunlight Special Storage Condition, Specify 0 0 Keep dry
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 276075371 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 true 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 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