Home GUDID 00190660121556 Ambler Surgical
Primary DI 00190660121556
Brand Ambler Surgical
Company AMBLER SURGICAL CORP.
Model R-Style needle
Catalog number 57-428
Device description R-Style needle, 7 1/2'', angled 45 degrees, semi-sharp tip, round handle, titanium
Published 2021-01-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HAS NEEDLE, NEUROSURGICAL SUTURE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HAS Needle, Neurosurgical Suture Neurology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190660121556 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 00190660121556 00190660121556 190660121556 0190660121556
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 Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 015272206 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 04262494463051 N/A Doppkon GmbH & Co. KG HAS 2025-12-04 00887482103579 Symmetry Rhoton® ASPEN SURGICAL PRODUCTS, INC. HAS 2024-09-05 00887482103593 Symmetry Rhoton® ASPEN SURGICAL PRODUCTS, INC. HAS 2024-08-01 00190776354619 MILLENNIUM Avalign Technologies, Inc. HAS 2023-09-28 00190776355067 MILLENNIUM Avalign Technologies, Inc. HAS 2023-09-28 14026704796929 PILLING TELEFLEX INCORPORATED HAS 2022-12-08 54026704796927 PILLING TELEFLEX INCORPORATED HAS 2022-12-08 00887482096215 Symmetry Adson ASPEN SURGICAL PRODUCTS, INC. HAS 2022-08-24 00190776068585 Avalign Avalign Technologies, Inc. HAS 2021-11-03 00190776068592 Avalign Avalign Technologies, Inc. HAS 2021-11-03 00190776211912 Avalign Avalign Technologies, Inc. HAS 2021-11-03 00190660121549 Ambler Surgical AMBLER SURGICAL CORP. HAS 2021-01-07 00190660109707 Ambler Surgical AMBLER SURGICAL CORP. HAS 2021-01-04 00190660121563 Ambler Surgical AMBLER SURGICAL CORP. HAS 2021-01-04 00190660121570 Ambler Surgical AMBLER SURGICAL CORP. HAS 2021-01-04 10885403072819 V. Mueller STERIS CORPORATION HAS 2018-08-30
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