Home GUDID 10806378029547
ACUMED
Primary DI 10806378029547
Brand ACUMED
Company Acumed LLC
Model 46-0002-S
Device description Acu-Sinch® Isolated Kit
Published 2015-10-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name HTN WASHER, BOLT NUT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTN Washer, Bolt Nut Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10806378029547 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10806378029547 10806378029547
GMDN Terms# Term, Definition table Term Definition General internal orthopaedic fixation system implantation kit A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.
Regulatory Flags# DUNS number 196884852 Device count 1 Kit true Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850080543009 PC Fix Locking Post Ti Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543016 PC Fix Locking Cap Ti Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543023 PC Fix Washer Ti Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543030 PC Fix Extrathoracic Plate 70mm Ti Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543047 PC Fix Extrathoracic Plate 95mm Ti Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543054 PC Fix Intrathoracic Plate 70mm Ti Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543061 PC Fix Intrathoracic Plate 95mm Ti Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543078 PC Fix Thoracic Plate 70mm PEEK Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543085 PC Fix Thoracic Plate 95mm PEEK Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543092 PC Fix 3.2mm Drill Brad Point QC Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543108 PC Fix Graphic Case Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543115 PC Fix Clamp/Drill Guide Top Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543122 PC Fix Clamp/Drill Guide Bottom Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543139 PC Fix Compression Clamp Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543146 PC Fix 3.2mm Drill Dental Latch Chest Wall Innovations, Inc. HTN 2026-06-01 00850080543184 PC Fix Implant Caddy Chest Wall Innovations, Inc. HTN 2026-06-01 07901125602533 Expert Knotless GM DOS REIS INDUSTRIA E COMERCIO LTDA HTN 2026-05-28 00888867251960 Arthrex® ARTHREX, INC. HTN 2017-11-28 00888867251939 Arthrex® ARTHREX, INC. HTN 2017-02-15 07613327075830 ASNIS Stryker GmbH HTN 2015-11-11 07613327076189 ASNIS Stryker GmbH HTN 2015-11-11 07613327076301 ASNIS Stryker GmbH HTN 2015-11-11 07613327076554 ASNIS Stryker GmbH HTN 2015-11-11 07613327076721 ASNIS Stryker GmbH HTN 2015-11-11 07613327076929 ASNIS Stryker GmbH HTN 2015-11-11 07613327077049 ASNIS Stryker GmbH HTN 2015-11-11 07613327073737 VARIAX Stryker GmbH HTN 2015-09-30 07613327073768 VARIAX Stryker GmbH HTN 2015-09-30 07613327073799 VARIAX Stryker GmbH HTN 2015-09-30 07613327073812 VARIAX Stryker GmbH HTN 2015-09-30