Home GUDID B8034709310 ORTHOMED
Primary DI B8034709310
Brand ORTHOMED
Company ORTHO-MED, INC.
Model OM 47-0931
Catalog number OM 47-0931
Device description "BENDING PLIERS 5 1/2"" 1.5 + 2.0MM"
Published 2026-03-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name HTC Pliers, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTC Pliers, Surgical General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B8034709310 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone fixation plate pliers A manual surgical instrument designed to bend and cut light-bone fixation plates (e.g., 1 to 2 mm in thickness), such as those used in craniomaxillofacial (CMF) or finger surgery. The instrument is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot to form jaws that bend and cut the metal plates allowing the surgeon to customize their size and shape. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 086618626 Device count 1 Premarket exempt true 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 B8034802690 ORTHOMED ORTHO-MED, INC. HTC 2026-04-16 B8034803700 ORTHOMED ORTHO-MED, INC. HTC 2026-04-16 B8034803720 ORTHOMED ORTHO-MED, INC. HTC 2026-04-16 00840105223818 ZOLL DENTAL Zoll-Dental HTC 2025-09-16 00840105223825 ZOLL DENTAL Zoll-Dental HTC 2025-09-16 00840105223832 ZOLL DENTAL Zoll-Dental HTC 2025-09-16 10887587077628 NA Synthes GmbH HTC 2024-08-21 B356KJ666140 American Medicals American Medicals HTC 2024-07-11 10840199539458 Forcep KOROS U.S.A., INC. HTC 2024-02-01 10840199539489 Forcep KOROS U.S.A., INC. HTC 2024-02-01 10840199535900 Clamp KOROS U.S.A., INC. HTC 2024-01-31 10840199535962 C Clamp KOROS U.S.A., INC. HTC 2024-01-31 10840199535993 Aortic Clamp KOROS U.S.A., INC. HTC 2024-01-31 10840199536006 Aortic Clamp KOROS U.S.A., INC. HTC 2024-01-31 B356KJ526120 American Medicals American Medicals HTC 2022-12-14 14026704799135 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799142 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799159 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799166 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799319 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799326 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704811448 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 10840199539830 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539847 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539854 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539861 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539878 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539885 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539892 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199543011 Forcep KOROS U.S.A., INC. HTC 2022-10-31