Home GUDID B8034803400 ORTHOMED
Primary DI B8034803400
Brand ORTHOMED
Company ORTHO-MED, INC.
Model OM 48-0340
Device description RUSH AWL AND REAMER 8 1/2" 5.0MM
Published 2026-07-16
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 HWJ Awl
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWJ Awl Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B8034803400 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone awl, reusable A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is 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, typically made of metallic and/or synthetic material. This is a reusable 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 B8034609130 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034609140 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034609150 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034609160 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034803030 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034803360 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034803370 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034803380 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034803390 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 B8034803410 ORTHOMED ORTHO-MED, INC. HWJ 2026-07-16 00857915007767 IM Nail Awl A.M. SURGICAL, INC. HWJ 2026-06-10 00840311245376 Streamline MIS Spinal Fixation System Xtant Medical Holdings, Inc. HWJ 2026-04-30 08800322758137 Anyplus ll Spinal Fixation System GS Medical Co., Ltd. HWJ 2026-04-21 00860015151308 EnFix Instrument Kit - Complete TETROUS, INC. HWJ 2026-02-24 00887868287473 Trinica ALP Anterior Lumbar Plate System Highridge Medical, LLC HWJ 2025-11-12 03662663108126 Trinica/Trinica Select Anterior Cervical Plate System Highridge Medical, LLC HWJ 2025-11-12 07640375234773 SCARLET AL-T INSTRUMENTATION SpineArt SA HWJ 2025-11-10 08059386744338 Orthopaedic Surgical Instruments CITIEFFE SRL HWJ 2025-11-06 00763000674410 n/a MEDTRONIC SOFAMOR DANEK, INC. HWJ 2025-10-26 09120129291507 Awl, Curved, Cannulated I.T.S. GmbH HWJ 2025-10-21 09120129291514 Awl Trocar I.T.S. GmbH HWJ 2025-10-21 00763000878245 n/a MEDTRONIC SOFAMOR DANEK, INC. HWJ 2025-10-20 00840180541050 General Instruments ALPHATEC SPINE, INC. HWJ 2025-10-17 00763000885243 n/a MEDTRONIC SOFAMOR DANEK, INC. HWJ 2025-10-11 00816342025522 AWL PARCUS MEDICAL LLC HWJ 2025-09-16 00841732142329 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2025-03-31 00841732142336 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2025-03-31 00841732151642 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2025-03-31 00841732151734 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2025-03-31 00841732160330 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2025-03-31