Home GUDID 00763000491789 Avyon™ 8FR Balloon Guide Catheter
Primary DI 00763000491789
Brand Avyon™ 8FR Balloon Guide Catheter
Company Micro Therapeutics, Inc.
Model 8F-087-95CM
Device description BALLOON GUIDE CATHETER 8F-087-95 CM V01
Published 2021-04-15
Public version status Update
Distribution status Not 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 DQY Catheter, percutaneous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQY Catheter, Percutaneous Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00763000491789 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 00763000491789 00763000491789 763000491789 0763000491789
GMDN Terms# Term, Definition table Term Definition Intravascular occluding balloon catheter, image-guided A flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 0 Percent (%) Relative Humidity 0.85 Percent (%) Relative Humidity Storage Environment Temperature 20 Degrees Fahrenheit 100 Degrees Fahrenheit
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 07613327623338 AXS Lift Stryker Corporation DQY 2025-03-04 07613327623376 AXS Lift Stryker Corporation DQY 2025-03-04 07613327417203 AXS Catalyst 7 Stryker Corporation DQY 2019-05-13 07613327417227 AXS Catalyst 7 Stryker Corporation DQY 2019-05-13 07613327313888 DAC 038 Stryker Corporation DQY 2016-09-21 07613327313901 DAC 057 Stryker Corporation DQY 2016-09-21 07613327313932 DAC 070 Stryker Corporation DQY 2016-09-21 07613327313949 DAC 057 Stryker Corporation DQY 2016-09-21 08033477054322 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054360 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054384 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054391 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054407 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054421 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054438 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477048772 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048802 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048833 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048864 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048888 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048925 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048956 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048987 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049014 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049045 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049069 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049076 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049106 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049137 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049168 REEF HP MEDTRONIC, INC. DQY 2016-06-19