Home GUDID M9935071630 GSO PCT Spinal System
Primary DI M9935071630
Brand GSO PCT Spinal System
Company UNIFIED SPINE, LLC
Model 507163
Device description Rod Holder
Published 2018-09-21
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 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 M9935071630 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant/trial-implant/sizer holder, reusable A hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft), trial implant, or sizer (e.g., glenoid defect sizer) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during an orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 118413370 Device count 1 Premarket exempt true 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 M9935042050 GSO GS1 Spinal System 504205 2018-09-21 M9935042180 GSO GS1 Spinal System 504218 2018-09-21 M9935042190 GSO GS1 Spinal System 504219 2018-09-21 M9935071650 GSO PCT Spinal System 507165 2018-09-21 M9935071760 GSO PCT Spinal System 507176 2018-09-21 M9935071770 GSO PCT Spinal System 507177 2018-09-21 M9935091200 GSO ACP1 Anterior Cervical Plate System 509120 2016-09-14 M9935091220 GSO ACP1 Anterior Cervical Plate System 509122 2016-09-14 M9935091240 GSO ACP1 Anterior Cervical Plate System 509124 2016-09-14 M9935091260 GSO ACP1 Anterior Cervical Plate System 509126 2016-09-14 M9935091280 GSO ACP1 Anterior Cervical Plate System 509128 2016-09-14 M9935091300 GSO ACP1 Anterior Cervical Plate System 509130 2016-09-15 M9935091320 GSO ACP1 Anterior Cervical Plate System 509132 2016-09-14 M9935092340 GSO ACP1 Anterior Cervical Plate System 509234 2016-09-15 M9935092370 GSO ACP1 Anterior Cervical Plate System 509237 2016-09-15 M9935092400 GSO ACP1 Anterior Cervical Plate System 509240 2016-09-15 M9935092430 GSO ACP1 Anterior Cervical Plate System 509243 2016-09-15 M9935092460 GSO ACP1 Anterior Cervical Plate System 509246 2016-09-15 M9935092490 GSO ACP1 Anterior Cervical Plate System 509249 2016-09-15 M9935092520 GSO ACP1 Anterior Cervical Plate System 509252 2016-09-15
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