Home GUDID 10888857411838 Brainlab Compatible K2M Navigation Instruments
Primary DI 10888857411838
Brand Brainlab Compatible K2M Navigation Instruments
Company VB Spine LLC
Model 101-N90228-B
Catalog number 101-N90228-B
Device description Awl Tap, Size 8.5mm DENALI
Published 2019-04-19
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name OLO Orthopedic stereotaxic instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OLO Orthopedic Stereotaxic Instrument Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10888857411838 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10888857411838 10888857411838
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.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 8.5 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 119508156 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10888857158313 TERRA NOVA® MI Access System 1501-90060 1501-90060 2021-01-29 10888857596894 OZARK Cervical Plate System PRO-1427-01 PRO-1427-01 2026-05-28 10888857596719 Xia® 3 PRO-1432-01 PRO-1432-01 2026-05-12 10888857596726 Xia® 3 PRO-1432-02 PRO-1432-02 2026-05-12 10888857596733 Xia® 3 PRO-1432-03 PRO-1432-03 2026-05-12 10888857219656 CASCADIA™ Interbody System 6101-2224012LL8-G2 6101-2224012LL8-G2 2016-12-30 10888857219793 CASCADIA™ Interbody System 6101-2226014LL8-G2 6101-2226014LL8-G2 2015-12-16 10888857220966 CASCADIA™ Interbody System 6101-2224510LL12-G2 6101-2224510LL12-G2 2016-12-30 10888857221093 CASCADIA™ Interbody System 6101-2226012LL12-G2 6101-2226012LL12-G2 2016-12-30 10888857221871 CASCADIA™ Interbody System 6101-2225014LL15-G2 6101-2225014LL15-G2 2016-12-30 10888857221895 CASCADIA™ Interbody System 6101-2226014LL15-G2 6101-2226014LL15-G2 2016-12-30 10888857346420 CANYON™ Retractor Systems 6401-90107 6401-90107 2020-06-18 10888857035553 RAVINE® Lateral Access System 2701-90072 2701-90072 2022-02-14 10888857596900 OZARK Cervical Plate System PRO-1427-10 PRO-1427-10 2026-05-01 10888857596917 OZARK Cervical Plate System PRO-1427-12 PRO-1427-12 2026-05-01 10888857596924 OZARK Cervical Plate System PRO-1427-14 PRO-1427-14 2026-05-01 10888857596931 OZARK Cervical Plate System PRO-1427-16 PRO-1427-16 2026-05-01 10888857596948 OZARK Cervical Plate System PRO-1427-18 PRO-1427-18 2026-05-01 10888857218765 CASCADIA™ Interbody System 6101-2224508LP-G2 6101-2224508LP-G2 2015-12-16 10888857218888 CASCADIA™ Interbody System 6101-2225510LP-G2 6101-2225510LP-G2 2015-12-16
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