Home GUDID 00199150045549 OnyxTM Liquid Embolic System (LES)
Primary DI 00199150045549
Brand OnyxTM Liquid Embolic System (LES)
Company Micro Therapeutics, Inc.
Model 105-7100-080
Device description LIQUID 105-7100-080 ONYX 34 V12 US
Published 2026-06-01
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
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 00199150045549 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 00199150045549 00199150045549 199150045549 0199150045549
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 Special Storage Condition, Specify 0 0 Device should be stored in a dry place, away from sunlight. Prior to use, maintain product temperature between 19 °C (66.2 °F) and 24 °C (75.2 °F). Special Storage Condition, Specify 0 0 If product freezes due to exposure to colder temperatures, thaw at room temperature before use.
Regulatory Flags# DUNS number 826110710 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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 00836462005044 Onyx 18 Micro Therapeutics, Inc. MFE 2014-09-22 00836462005051 Onyx 34 Micro Therapeutics, Inc. MFE 2014-09-22
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