Home GUDID M97023000204509 Eclipse
Primary DI M97023000204509
Brand Eclipse
Company Medshape, Inc.
Model 1500-01-045
Device description Procedure Pack, 4.5MM Sterile Cannulated Drill/Reamer
Published 2015-12-15
Public version status Update
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 M97023000204509 Direct Marking HIBCC 0 M97015000104509 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Cannulated surgical drill bit, single-use A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.
Regulatory Flags# DUNS number 601306413 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 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 B803SYN31005100 ORTHOMED ORTHO-MED, INC. HTW 2026-07-22 B803SYN310230 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