Home GUDID B35645724070 American Medicals
Primary DI B35645724070
Brand American Medicals
Company American Medicals
Model 1
Published 2022-09-09
Public version status Update
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 GDG Hook, Surgical, General & Plastic Surgery
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B35645724070 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Middle ear incus hook A shaft-like, hand-held manual surgical instrument intended to be used during ear/nose/throat (ENT) surgery for fixation or traction of the incus bone (the anvil bone of the group of three that form the sound-transmitting ossicles in the middle ear). The device tapers towards the distal end to form a hook or multiple hooks used in the procedure. The proximal end forms a handle which may vary in shape. In multiple hook designs, the hooks are in parallel. This is a reusable device.
Sterilization Methods# Method table Method Microwave Radiation
Regulatory Flags# DUNS number 109909627 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false 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 B033K94140 9" Nerve Hook Kapp Surgical Instrument Co. GDG 2026-08-27 00810158215955 PRINCETON Princeton Medical Group, Inc. GDG 2026-08-25 10850067560323 MaxRetract Surgical Principals, Inc GDG 2026-08-25 10850067560330 MaxRetract Surgical Principals, Inc GDG 2026-08-25 10850067560347 MaxRetract Surgical Principals, Inc GDG 2026-08-25 00190776419660 Millennium Avalign Technologies, Inc. GDG 2026-08-23 00190776417161 Millennium Avalign Technologies, Inc. GDG 2026-08-19 00190776417079 Millennium Avalign Technologies, Inc. GDG 2026-08-18 00190776422219 Millennium Avalign Technologies, Inc. GDG 2026-07-31 00190776407346 Millennium Avalign Technologies, Inc. GDG 2026-07-28 B382SD907072080 Surgical Direct Surgical Direct, Inc. GDG 2026-07-27 B382SD907072090 Surgical Direct Surgical Direct, Inc. GDG 2026-07-27 B382SD9147096600 Surgical Direct Surgical Direct, Inc. GDG 2026-07-27 B382SD9147096610 Surgical Direct Surgical Direct, Inc. GDG 2026-07-27 00850088713176 PRINCETON Princeton Medical Group, Inc. GDG 2026-07-23 00840183531232 BR Surgical, LLC BR Surgical, LLC GDG 2026-07-21 B382SD907505200 Surgical Direct Surgical Direct, Inc. GDG 2026-07-17 B382SD907505210 Surgical Direct Surgical Direct, Inc. GDG 2026-07-17 00190776395674 Millennium Avalign Technologies, Inc. GDG 2026-07-14 00810158216136 PRINCETON Princeton Medical Group, Inc. GDG 2026-06-23 B7685252430 Buxton BioMedical Buxton Biomedical Inc GDG 2026-06-05 G383S1061WM3245624S7 SURJEX SURJEX GDG 2026-05-31 00810055258734 Surgical Design Surgical Design, Inc. GDG 2026-05-29 00810055258741 Surgical Design Surgical Design, Inc. GDG 2026-05-29 00810055258758 Surgical Design Surgical Design, Inc. GDG 2026-05-29 00810055258765 Surgical Design Surgical Design, Inc. GDG 2026-05-29 00810055258772 Surgical Design Surgical Design, Inc. GDG 2026-05-29 00810055258789 Surgical Design Surgical Design, Inc. GDG 2026-05-29 00810055258796 Surgical Design Surgical Design, Inc. GDG 2026-05-29 00810055258802 Surgical Design Surgical Design, Inc. GDG 2026-05-29