Home GUDID 00836462005044 Onyx 18
Primary DI 00836462005044
Brand Onyx 18
Company Micro Therapeutics, Inc.
Model 105-7100-060
Device description Liquid Embolic 105-7100-060 Onyx 18
Published 2014-09-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MFE Agent, injectable, embolic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MFE Agent, Injectable, Embolic Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00836462005044 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 00836462005044 00836462005044 836462005044 0836462005044
GMDN Terms# Term, Definition table Term Definition Neurovascular embolization plug A sterile, 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 19 Degrees Celsius 24 Degrees Celsius Special Storage Condition, Specify 0 0 Keep dry;AVOID DIRECT SUNLIGHT Storage Environment Temperature -20 Degrees Celsius 55 Degrees Celsius
Regulatory Flags# DUNS number 826110710 Device count 1 Kit true Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00199150045532 OnyxTM Liquid Embolic System (LES) Micro Therapeutics, Inc. MFE 2026-06-07 00199150045549 OnyxTM Liquid Embolic System (LES) Micro Therapeutics, Inc. MFE 2026-06-01 00763000925338 OnyxTM Liquid Embolic System (LES) Micro Therapeutics, Inc. MFE 2026-01-02 00763000925352 OnyxTM Liquid Embolic System (LES) Micro Therapeutics, Inc. MFE 2026-01-02 00763000446741 Apollo Micro Therapeutics, Inc. MFE 2022-11-13 00763000446758 Apollo Micro Therapeutics, Inc. MFE 2022-11-13 00847536006010 ApolloTM Micro Therapeutics, Inc. MFE 2016-09-26 00847536006041 ApolloTM Micro Therapeutics, Inc. MFE 2016-09-26 00836462002463 Apollo Onyx Micro Therapeutics, Inc. MFE 2015-06-08 00836462002487 Apollo Onyx Micro Therapeutics, Inc. MFE 2015-06-08 00847536006171 ONYX 18 Micro Therapeutics, Inc. MFE 2015-04-17 00847536006188 ONYX 34 Micro Therapeutics, Inc. MFE 2015-04-17 00836462005051 Onyx 34 Micro Therapeutics, Inc. MFE 2014-09-22
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