Home GUDID B803SYN310230 ORTHOMED
Primary DI B803SYN310230
Brand ORTHOMED
Company ORTHO-MED, INC.
Model OM SYN310.23
Device description DRILL BIT QC 2.5MM 180MM 45MM FLUTE
Published 2026-07-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false 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 B803SYN310230 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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 086618626 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 B803SYN31005100 ORTHOMED ORTHO-MED, INC. HTW 2026-07-22 B803SYN310650 ORTHOMED ORTHO-MED, INC. HTW 2026-07-22 B803SYN310660 ORTHOMED ORTHO-MED, INC. HTW 2026-07-22 B803SYN310670 ORTHOMED ORTHO-MED, INC. HTW 2026-07-22 B803SYN310680 ORTHOMED ORTHO-MED, INC. HTW 2026-07-22 00190776403270 Millennium Avalign Technologies, Inc. HTW 2026-07-21 08059386748688 Orthopaedic Surgical Instruments CITIEFFE SRL HTW 2026-07-21 B504OM19S17050 Brasseler Provision HTW 2026-07-20 B504OM3162880 Synthes Provision HTW 2026-07-20 B504OM4058830 Biomet Provision HTW 2026-07-20 B504OM4058890 Biomet Provision HTW 2026-07-20 B504OM542022S0 Stryker Provision HTW 2026-07-20 B504OM7024470 Stryker Provision HTW 2026-07-20 B504OMA37330 Medartis Provision HTW 2026-07-20 B504OMAR1214L0 Arthrex Provision HTW 2026-07-20 B504OMAR1217L0 Arthrex Provision HTW 2026-07-20 B504OMCSS07247SQ0 Wright Provision HTW 2026-07-20 B504OMKM166310260 Brasseler Provision HTW 2026-07-20 B504OMKM166310680 Brasseler Provision HTW 2026-07-20 00190776400552 Millennium Avalign Technologies, Inc. HTW 2026-07-19 00190776400576 Millennium Avalign Technologies, Inc. HTW 2026-07-19 00190776400644 Millennium Avalign Technologies, Inc. HTW 2026-07-19 00190776402075 Millennium Avalign Technologies, Inc. HTW 2026-07-19 00190776402082 Millennium Avalign Technologies, Inc. HTW 2026-07-19 00190776402204 Millennium Avalign Technologies, Inc. HTW 2026-07-19 00190776400293 Millennium Avalign Technologies, Inc. HTW 2026-07-17 18257200076536 CETRA Orthofix US LLC HTW 2026-07-17 18257200076574 CETRA Orthofix US LLC HTW 2026-07-17 18257200131211 Firebird SI Fusion Orthofix US LLC HTW 2026-07-17 18257200131228 Firebird SI Fusion Orthofix US LLC HTW 2026-07-17