Home GUDID M97010001004504 Morphix
Primary DI M97010001004504
Brand Morphix
Company Medshape, Inc.
Model 1000-10-045
Device description MORPHIX 4.5mm Single Use Drill and Guide Procedure Pack, Sterile
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 M97010001004504 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical drill guide, single-use A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.
Regulatory Flags# DUNS number 601306413 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true 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 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 18257200131273 Firebird SI Fusion Orthofix US LLC HTW 2026-07-17 18257200163823 PILLAR SA Ti Orthofix US LLC HTW 2026-07-17 18257200163854 PILLAR SA Ti Orthofix US LLC HTW 2026-07-17 07630008439866 APTUS Medartis AG HTW 2026-07-16 07630037811374 APTUS Medartis AG HTW 2026-07-16 09353903030225 OCTOPi Suture Anchor System FIELD ORTHOPAEDICS PTY LTD HTW 2026-07-15 09353903030317 OCTOPi Suture Anchor System FIELD ORTHOPAEDICS PTY LTD HTW 2026-07-15 09353903030324 OCTOPi Suture Anchor System FIELD ORTHOPAEDICS PTY LTD HTW 2026-07-15 00190776395438 Millennium Avalign Technologies, Inc. HTW 2026-07-13 00190446932406 Arsenal Foot Trilliant Surgical, LLC HTW 2026-06-25 00190446948216 Arsenal Foot Trilliant Surgical, LLC HTW 2026-06-25 00190446948483 Arsenal Foot Trilliant Surgical, LLC HTW 2026-06-25 09353903030218 Griplasty System FIELD ORTHOPAEDICS PTY LTD HTW 2026-06-24 00889795154507 Spider Monkey Bone Transport System Paragon 28, Inc. HTW 2026-06-10 00889795154514 Spider Monkey Bone Transport System Paragon 28, Inc. HTW 2026-06-10 00889795154521 Spider Monkey Bone Transport System Paragon 28, Inc. HTW 2026-06-10 00889795154606 Spider Monkey Bone Transport System Paragon 28, Inc. HTW 2026-06-10 08800089483433 Drill bit Jeil Medical Corporation HTW 2026-06-10 08800089483457 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTW 2026-06-10