Home GUDID 00763000446741 Apollo
Primary DI 00763000446741
Brand Apollo
Company Micro Therapeutics, Inc.
Model 105-5095-000
Device description MICRO CATH 105-5095-000 V08 APOLLO 1.5CM
Published 2022-11-13
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
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 00763000446741 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 00763000446741 00763000446741 763000446741 0763000446741
GMDN Terms# Term, Definition table Term Definition Vascular microcatheter A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.
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
Regulatory Flags# DUNS number 826110710 Device count 1 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 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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