Home GUDID 10806378123832 ACUMED
Primary DI 10806378123832
Brand ACUMED
Company Acumed LLC
Model 47-0018-S
Device description 3.5mm Cannulated Drill & 1.3mm K-wire
Published 2024-04-06
Public version status New
Distribution status 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 LXH Orthopedic manual surgical instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10806378123832 Primary GS1 0 10806378123795 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10806378123832 10806378123832 10806378123795 10806378123795
GMDN Terms# Term, Definition table Term Definition General external orthopaedic fixation system implantation kit, single-use A collection of non-sterile, manual surgical instruments intended to be used for the placement of an external orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It includes various instruments [e.g., retractors, rods, clamps, drills, pins/screws, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of external orthopaedic fixation system (i.e., non-dedicated); it does not include any implantable devices. This is a single-use device.
Regulatory Flags# DUNS number 196884852 Device count 2 DM exempt true Premarket exempt true Kit true Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00199150075034 Medtronic Reusable Instruments MEDTRONIC SOFAMOR DANEK, INC. LXH 2026-07-10 07640177820907 Neo Medical Pedicle screw kit Neo Medical SA LXH 2026-07-10 00840286860093 Tahoe Unicompartmental Knee System Shalby Advanced Technologies, Inc. LXH 2026-07-09 00840286860109 Tahoe Unicompartmental Knee System Shalby Advanced Technologies, Inc. LXH 2026-07-09 00840286860116 Tahoe Unicompartmental Knee System Shalby Advanced Technologies, Inc. LXH 2026-07-09 10705034647463 N/A Medos International Sàrl LXH 2026-07-09 B382SD49400B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49401B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49402B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49403B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49404B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49405B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49406B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49407B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49408B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49409B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49410B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49411B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49412B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49413B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49414B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49415B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49416B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49417B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49418B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49419B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49420B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500010 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500020 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500030 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09
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