Home GUDID B504OMKM166310680 Brasseler
Primary DI B504OMKM166310680
Brand Brasseler
Company Provision
Model KM166-310-68
Published 2026-07-20
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 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 B504OMKM166310680 Primary HIBCC 0
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.
Regulatory Flags# DUNS number 016889401 Device count 1 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 false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00889795150141 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150158 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150165 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150172 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150189 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150196 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150202 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150219 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150226 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150233 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150240 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150257 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795151728 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00190446960324 DYNANAIL HELIX Medshape, Inc. HTW 2026-10-09 00190446960331 DYNANAIL HELIX Medshape, Inc. HTW 2026-10-09 00190446960348 DYNANAIL HELIX Medshape, Inc. HTW 2026-10-09 00190446960409 DYNANAIL HELIX Medshape, Inc. HTW 2026-10-09 00190446960416 DYNANAIL HELIX Medshape, Inc. HTW 2026-10-09 00889024715271 Affixus® Zimmer, Inc. HTW 2026-10-06 10886982345431 VOLT Synthes GmbH HTW 2026-09-25 10886982345479 VOLT Synthes GmbH HTW 2026-09-25 00888867574540 Arthrex® ARTHREX, INC. HTW 2026-09-18 00888867574557 Arthrex® ARTHREX, INC. HTW 2026-09-18 10810128463079 OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mm T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION HTW 2026-08-23 10810128463086 OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mm T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION HTW 2026-08-23 10810128463185 OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mm T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION HTW 2026-08-23 10810128463192 OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mm T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION HTW 2026-08-23 00884450681381 Preston™ Merit Medical Systems, Inc. HTW 2026-08-21 00884450681398 Preston™ Merit Medical Systems, Inc. HTW 2026-08-21 00840606191791 Overwatch PCF SPINAL ELEMENTS, INC. HTW 2026-07-31
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