Home GUDID 10806378043239 ACUMED
Primary DI 10806378043239
Brand ACUMED
Company Acumed LLC
Model 80-0587
Device description Acutrak® Screw Removal Tray Base
Published 2015-10-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name FSM TRAY, SURGICAL, INSTRUMENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FSM Tray, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10806378043239 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10806378043239 10806378043239
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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 196884852 Device count 1 Premarket exempt true Lot or batch 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 00889929072400 NEXXT MATRIXX® SI System NEXXT SPINE, LLC FSM 2026-07-10 07640177821393 Neo Medical Pedicle screw kit Neo Medical SA FSM 2026-07-10 07640177821409 Neo Medical Pedicle screw kit Neo Medical SA FSM 2026-07-10 07640177821416 Neo Medical Pedicle screw kit Neo Medical SA FSM 2026-07-10 G079IVA22025000 Golden Isles Pedicle Screw System Intelivation, LLC FSM 2026-07-10 G079IVA22026000 Golden Isles Pedicle Screw System Intelivation, LLC FSM 2026-07-10 00840286860086 Consensus Knee System Shalby Advanced Technologies, Inc. FSM 2026-07-09 M697X07900081 Silex Sacroiliac Joint Fusion System Xtant Medical Holdings, Inc. FSM 2026-07-08 00840456220283 JMU JMU DENTAL, INC FSM 2026-07-07 00190446907466 EF1 Medshape, Inc. FSM 2026-06-25 00190446907473 EF1 Medshape, Inc. FSM 2026-06-25 00190776421724 Millennium Avalign Technologies, Inc. FSM 2026-06-24 00885556924730 EVOS Smith & Nephew, Inc. FSM 2026-06-24 00840456200308 JMU JMU DENTAL, INC FSM 2026-06-23 00840456200315 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201176 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201206 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201213 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201220 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201237 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201244 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201251 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201268 JMU JMU DENTAL, INC FSM 2026-06-23 00840456206706 JMU JMU DENTAL, INC FSM 2026-06-23 00840456206713 JMU JMU DENTAL, INC FSM 2026-06-23 00840456207000 JMU JMU DENTAL, INC FSM 2026-06-23 00840456214077 JMU JMU DENTAL, INC FSM 2026-06-23 00840456214084 JMU JMU DENTAL, INC FSM 2026-06-23 00840456214091 JMU JMU DENTAL, INC FSM 2026-06-23 00840456214107 JMU JMU DENTAL, INC FSM 2026-06-23
acumed.net