Home GUDID 10806378041891
ACUMED
Primary DI 10806378041891
Brand ACUMED
Company Acumed LLC
Model 80-0399
Device description Drill, Left Hand 1.5mm, QR
Published 2015-10-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name HTW BIT, DRILL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTW Bit, Drill Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10806378041891 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10806378041891 10806378041891
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 00190446932406 Arsenal Foot Trilliant Surgical, LLC HTW 2026-06-25 00190446948216 Arsenal Foot Trilliant Surgical, LLC HTW 2026-06-25 00190446948483 Arsenal Foot Trilliant Surgical, LLC HTW 2026-06-25 09353903030218 Griplasty System FIELD ORTHOPAEDICS PTY LTD HTW 2026-06-24 00889795154507 Spider Monkey Bone Transport System Paragon 28, Inc. HTW 2026-06-10 00889795154514 Spider Monkey Bone Transport System Paragon 28, Inc. HTW 2026-06-10 00889795154521 Spider Monkey Bone Transport System Paragon 28, Inc. HTW 2026-06-10 00889795154606 Spider Monkey Bone Transport System Paragon 28, Inc. HTW 2026-06-10 08800089483433 Drill bit Jeil Medical Corporation HTW 2026-06-10 08800089483457 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTW 2026-06-10 04052536176700 neon3 Ulrich GmbH & Co. KG HTW 2026-06-08 04052536176717 neon3 Ulrich GmbH & Co. KG HTW 2026-06-08 00196449017355 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017362 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017409 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017416 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017423 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017430 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017447 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017461 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017478 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017485 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017492 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017508 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017515 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017522 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017539 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017546 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017560 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017577 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04