Home GUDID 00836462002463 Apollo Onyx
Primary DI 00836462002463
Brand Apollo Onyx
Company Micro Therapeutics, Inc.
Model 105-5095-000
Catalog number 105-5095-000
Device description Delivery Micro Catheter
Published 2015-06-08
Public version status Update
Distribution status 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 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 00836462002463 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 00836462002463 00836462002463 836462002463 0836462002463
GMDN Terms# Term, Definition table Term Definition Vascular guide-catheter, single-use A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Length 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT Storage 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 true 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 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 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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