Home GUDID M364111106FD430 Asfora Anterior Cervical Plate System
Primary DI M364111106FD430
Brand Asfora Anterior Cervical Plate System
Company MEDICAL DESIGNS LLC
Model 11-1106-FD43
Device description Axial Driver Handle
Published 2016-09-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name KWQ Appliance, Fixation, Spinal Intervertebral Body
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 11110643 Direct Marking HIBCC 0 M364111106FD430 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Manual surgical rotary handpiece, reusable A manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 003815548 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 M364111106FD1220 Asfora Anterior Cervical Plate System 11-1106-FD1-22 2016-09-27 M364111106FD1240 Asfora Anterior Cervical Plate System 11-1106-FD1-24 2016-09-27 M364111106FD1260 Asfora Anterior Cervical Plate System 11-1106-FD1-26 2016-09-27 M364111106FD1280 Asfora Anterior Cervical Plate System 11-1106-FD1-28 2016-09-27 M364111106FD1300 Asfora Anterior Cervical Plate System 11-1106-FD1-30 2016-09-27 M364111106FD1320 Asfora Anterior Cervical Plate System 11-1106-FD1-32 2016-09-27 M364111106FD1340 Asfora Anterior Cervical Plate System 11-1106-FD1-34 2016-09-27 M364111106FD2320 Asfora Anterior Cervical Plate System 11-1106-FD2-32 2016-09-27 M364111106FD2350 Asfora Anterior Cervical Plate System 11-1106-FD2-35 2016-09-27 M364111106FD2380 Asfora Anterior Cervical Plate System 11-1106-FD2-38 2016-09-27 M364111106FD2410 Asfora Anterior Cervical Plate System 11-1106-FD2-41 2016-09-27 M364111106FD2440 Asfora Anterior Cervical Plate System 11-1106-FD2-44 2016-09-27 M364111106FD2470 Asfora Anterior Cervical Plate System 11-1106-FD2-47 2016-09-27 M364111106FD2500 Asfora Anterior Cervical Plate System 11-1106-FD2-50 2016-09-27 M364111106FD350 Asfora Anterior Cervical Plate System 11-1106-FD35 2016-09-27 M364111106FD3510 Asfora Anterior Cervical Plate System 11-1106-FD3-51 2016-09-27 M364111106FD3540 Asfora Anterior Cervical Plate System 11-1106-FD3-54 2016-09-27 M364111106FD3570 Asfora Anterior Cervical Plate System 11-1106-FD3-57 2016-09-27 M364111106FD3600 Asfora Anterior Cervical Plate System 11-1106-FD3-60 2016-09-27 M364111106FD3630 Asfora Anterior Cervical Plate System 11-1106-FD3-63 2016-09-27
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