Home GUDID 00842078121009 KinematX Total
Primary DI 00842078121009
Brand KinematX Total
Company EXTREMITY MEDICAL, LLC
Model 137-00006
Device description Radial Cartilage Removal Tool - Size 2
Published 2026-10-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name GAC Rasp, Surgical, General & Plastic Surgery
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00842078121009 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00842078121009 00842078121009 842078121009 0842078121009
GMDN Terms# Term, Definition table Term Definition Bone file/rasp, reciprocating, single-use A surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to be attached to a reciprocating power tool handpiece to scrape and smooth the surface of bone during a surgical procedure. It has grooves/teeth along all or part of the distal working end and is made of metal [e.g., stainless steel, titanium (Ti)]; it is not dedicated for use at a specific anatomy (e.g., sinus, ear). This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 832720358 Device count 1 DM exempt false 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 false 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 00842078102244 Omni MTP EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078102251 Omni MTP EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078102268 Omni MTP EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078102299 Omni MTP EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078102305 Omni MTP EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078102312 Omni MTP EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078107973 XMCP EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078107980 XMCP EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078108017 XMCP EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078108024 XMCP EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078108291 APEX EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078108307 APEX EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078108338 APEX EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078108345 APEX EXTREMITY MEDICAL, LLC GAC 2026-10-28 00842078116104 Omni Plating EXTREMITY MEDICAL, LLC GAC 2026-10-28 00190776434533 Millennium Avalign Technologies, Inc. GAC 2026-10-07 00724995267940 Snowden-Pencer STERIS Deutschland GmbH GAC 2026-09-25 00724995267957 Snowden-Pencer STERIS Deutschland GmbH GAC 2026-09-25 00190776397067 Millennium Avalign Technologies, Inc. GAC 2026-07-16 10888277374324 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-02-14 10888277382992 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-02-14 10080196382989 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10080196384983 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277374515 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277377004 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277377011 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277377509 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277381971 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277382442 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277384286 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29