Home GUDID 00836462005129 Onyx HD 500
Primary DI 00836462005129
Brand Onyx HD 500
Company Micro Therapeutics, Inc.
Model 105-8101-500
Device description 105-8101-500 ONYX HD500 KIT ANEURYS
Published 2014-09-22
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name OBA Polymerizing, neurovascular embolization material
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OBA Polymerizing, Neurovascular Embolization Material Unknown f
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00836462005129 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00836462005129 00836462005129 836462005129 0836462005129
GMDN Terms# Term, Definition table Term Definition Neurovascular embolization plug A non-bioabsorbable material (e.g., gel, liquid) intended to be implanted in a neurovascular blood vessel, to obstruct blood flow to treat a brain arteriovenous malformation (bAVM). It may be supplied as a liquid [e.g., ethylene vinyl alcohol (EVOH)], gel or powder intended to solidify or expand in situ to create a barrier to blood flow (embolus); it contains no pharmaceutical agents. It may be supplied with dedicated instruments for implantation.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 0
Regulatory Flags# DUNS number 826110710 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# 
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