Home GUDID 00810021836539 Medfix
Primary DI 00810021836539
Brand Medfix
Company MEDFIX INTERNATIONAL, LLC
Model MF337-1000
Device description Medfix® Lenke Pedicle Probe, Palm Blue Handle, Curved
Published 2020-04-03
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 HXB PROBE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HXB Probe Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810021836539 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810021836539 00810021836539 810021836539 0810021836539
GMDN Terms# Term, Definition table Term Definition Bone awl A spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 079699357 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 00199150069675 Medtronic Reusable Instruments MEDTRONIC SOFAMOR DANEK, INC. HXB 2026-03-20 10705034577449 N/A Medos International Sàrl HXB 2026-03-05 10889981443436 Specials Seaspine Orthopedics Corporation HXB 2026-03-03 10888857578197 Vulcan™ Spinal System K2M, INC. HXB 2026-02-20 10888857578203 Vulcan™ Spinal System K2M, INC. HXB 2026-02-20 10888857578630 Vulcan™ Spinal System K2M, INC. HXB 2026-02-20 10888857578647 Vulcan™ Spinal System K2M, INC. HXB 2026-02-20 10888857578654 Vulcan™ Spinal System K2M, INC. HXB 2026-02-20 10888857578661 Vulcan™ Spinal System K2M, INC. HXB 2026-02-20 10888857578678 Vulcan™ Spinal System K2M, INC. HXB 2026-02-20 10888857578685 Vulcan™ Spinal System K2M, INC. HXB 2026-02-20 10888857578692 Vulcan™ Spinal System K2M, INC. HXB 2026-02-20 10888857578708 Vulcan™ Spinal System K2M, INC. HXB 2026-02-20 03662663131551 Polaris 5.5 Spinal Fixation System Highridge Medical, LLC HXB 2026-02-11 03662663131568 Polaris 5.5 Spinal Fixation System Highridge Medical, LLC HXB 2026-02-11 03662663131575 Polaris 5.5 Spinal Fixation System Highridge Medical, LLC HXB 2026-02-11 03662663131582 Polaris 5.5 Spinal Fixation System Highridge Medical, LLC HXB 2026-02-11 03662663131599 Polaris 5.5 Spinal Fixation System Highridge Medical, LLC HXB 2026-02-11 03662663131605 Polaris 5.5 Spinal Fixation System Highridge Medical, LLC HXB 2026-02-11 03662663131612 Polaris 5.5 Spinal Fixation System Highridge Medical, LLC HXB 2026-02-11 00860014213458 Introducer Probe TETROUS, INC. HXB 2026-02-10 00860014213472 Pusher Probe TETROUS, INC. HXB 2026-02-10 00860014213496 Introducer Probe - SJ TETROUS, INC. HXB 2026-02-10 00810158218833 PRINCETON Princeton Medical Group, Inc. HXB 2026-02-05 00810158218840 PRINCETON Princeton Medical Group, Inc. HXB 2026-02-05 00810158218857 PRINCETON Princeton Medical Group, Inc. HXB 2026-02-05 00810158218864 PRINCETON Princeton Medical Group, Inc. HXB 2026-02-05 10889981441531 Specials Seaspine Orthopedics Corporation HXB 2026-01-30 00840180544013 General Instruments ALPHATEC SPINE, INC. HXB 2026-01-29 00840180545188 General Instruments ALPHATEC SPINE, INC. HXB 2026-01-29
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