Home GUDID 10806378121401 ACUMED
Primary DI 10806378121401
Brand ACUMED
Company Acumed LLC
Model 80-4118
Device description Acutrak 3 Mini/Standard Wire/Drill Guide
Published 2023-07-29
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 10806378121401 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10806378121401 10806378121401
GMDN Terms# Term, Definition table Term Definition Surgical drill guide, single-use A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use 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 Manufacturing date on label 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 00810166522816 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522823 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522830 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522847 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522854 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522861 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522878 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00889929072424 Matrixx System NEXXT SPINE, LLC LXH 2026-05-27 07640187918809 Straight reamer handle MPS Micro Precision Systems AG LXH 2026-05-27 07613327007114 ES2 SPINAL SYSTEM Stryker Corporation LXH 2019-11-25 07613327007558 XIA 3 Stryker Corporation LXH 2019-11-25 07613327007565 XIA 3 Stryker Corporation LXH 2019-11-25 07613327114881 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327121919 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327126273 AVS Anchor-C Cervical Cage System Stryker Corporation LXH 2019-11-25 07613327142662 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327142679 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327177480 OASYS Stryker Corporation LXH 2019-11-25 07613327261752 DIAPASON Stryker Corporation LXH 2019-11-25 07613327261943 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261950 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261967 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261974 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261998 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262001 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262018 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262025 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262032 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262049 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262056 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25
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