Home GUDID B8034803530 ORTHOMED
Primary DI B8034803530
Brand ORTHOMED
Company ORTHO-MED, INC.
Model OM 48-0353
Device description SCREW DRIVER HEX. 12" 3.5MM W/NOTCH
Published 2026-07-14
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 LRZ Screwdriver, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LRZ Screwdriver, Surgical General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B8034803530 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical screwdriver, reusable A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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 B8034500040 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034709510 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034709530 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034709540 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034709560 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034709580 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034709610 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803480 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803490 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803500 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803520 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803540 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803550 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803560 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803580 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803600 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803620 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 00196449017348 A.L.P.S. mvX™ Tyber Medical, LLC LRZ 2026-06-04 00196449017379 A.L.P.S. mvX™ Tyber Medical, LLC LRZ 2026-06-04 00196449017386 A.L.P.S. mvX™ Tyber Medical, LLC LRZ 2026-06-04 00196449017393 A.L.P.S. mvX™ Tyber Medical, LLC LRZ 2026-06-04 00196449017454 A.L.P.S. mvX™ Tyber Medical, LLC LRZ 2026-06-04 00196449017553 A.L.P.S. mvX™ Tyber Medical, LLC LRZ 2026-06-04 00841731137951 TITANEX VILEX LLC LRZ 2026-05-15 00841731137968 TITANEX VILEX LLC LRZ 2026-05-15 00841731138149 TITANEX VILEX LLC LRZ 2026-05-15 00841731140784 TITANEX VILEX LLC LRZ 2026-05-15 00841731141927 TITANEX VILEX LLC LRZ 2026-05-15 00841731146816 TITANEX VILEX LLC LRZ 2026-05-15 00841731146823 TITANEX VILEX LLC LRZ 2026-05-15