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 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 00840606191807 Overwatch PCF SPINAL ELEMENTS, INC. HTW 2026-07-31 00840606191814 Overwatch PCF SPINAL ELEMENTS, INC. HTW 2026-07-31 00840606191821 Overwatch PCF SPINAL ELEMENTS, INC. HTW 2026-07-31 00840606191852 Overwatch PCF SPINAL ELEMENTS, INC. HTW 2026-07-31 00840606195768 Overwatch PCF SPINAL ELEMENTS, INC. HTW 2026-07-31 00840606195775 Overwatch PCF SPINAL ELEMENTS, INC. HTW 2026-07-31 00190376544397 Invictus ALPHATEC SPINE, INC. HTW 2026-07-30 00190376544403 Invictus ALPHATEC SPINE, INC. HTW 2026-07-30 00190376544410 Invictus ALPHATEC SPINE, INC. HTW 2026-07-30 00190376544427 Invictus ALPHATEC SPINE, INC. HTW 2026-07-30 00190376544434 Invictus ALPHATEC SPINE, INC. HTW 2026-07-30 00190376544441 Invictus ALPHATEC SPINE, INC. HTW 2026-07-30 00190376544458 Invictus ALPHATEC SPINE, INC. HTW 2026-07-30 00190376544465 Invictus ALPHATEC SPINE, INC. HTW 2026-07-30 00190376544472 Invictus ALPHATEC SPINE, INC. HTW 2026-07-30 00190376544489 Invictus ALPHATEC SPINE, INC. HTW 2026-07-30 00190376544861 Invictus ALPHATEC SPINE, INC. HTW 2026-07-30 00190376544878 Invictus ALPHATEC SPINE, INC. HTW 2026-07-30 03701089515153 AMPLITUDE AMPLITUDE SAS HTW 2026-07-29