Home GUDID 00842078123331 Omni Stable AF
Primary DI 00842078123331
Brand Omni Stable AF
Company EXTREMITY MEDICAL, LLC
Model 155-03510
Device description 3.6mm Drill
Published 2026-10-29
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 HTW Bit, Drill
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTW Bit, Drill Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00842078123331 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 00842078123331 00842078123331 842078123331 0842078123331
GMDN Terms# Term, Definition table Term Definition Fluted surgical drill bit, single-use A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. 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 false 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 00842078100363 IO FiX EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078100370 IO FiX EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078100387 IO FiX EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078101773 XMCP EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078103197 IO FiX 2.0 EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078103227 IO FiX 2.0 EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078109465 CarpalFiX EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078110379 AlignX EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078112304 Axis Beams EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078112311 Axis Beams EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078112328 Axis Beams EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078112335 Axis Beams EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078112342 Axis Beams EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078112489 Axis Beams EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078112496 Axis Beams EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078112557 Axis Beams EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078112564 Axis Beams EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078114797 Omni MTP EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078114803 Omni MTP EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078114865 Omni MTP EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078117910 Axis Plating EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078117934 Axis Plating EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078117941 Axis Plating EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078118061 Axis Plating EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078123089 Omni Stable AF EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078124024 Omni Stable AF EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078124031 Omni Stable AF EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078124048 Omni Stable AF EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078125717 Omni Mini EXTREMITY MEDICAL, LLC HTW 2026-10-29 00842078125731 Omni Mini EXTREMITY MEDICAL, LLC HTW 2026-10-29