Home GUDID 08714729991069 Direxion™ HI-FLO™ Fathom™-16 System
Primary DI 08714729991069
Brand Direxion™ HI-FLO™ Fathom™-16 System
Company BOSTON SCIENTIFIC CORPORATION
Model M001195960
Catalog number M001195960
Device description Pre-Loaded Torqueable Microcatheter
Published 2019-07-18
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 KRA Catheter, continuous flush
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRA Catheter, Continuous Flush Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08714729991069 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08714729991069 08714729991069 8714729991069
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.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Inner Diameter 0.027 Inch Catheter Working Length 155 Centimeter Guidewire Length 200 Centimeter
Regulatory Flags# DUNS number 021717889 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published G4533352797GM8M50 PEAK MEDICAL Peak Medical Distribution Inc. KRA 2026-05-27 07640132622690 M-CATH Flexy Acrostak (Schweiz) AG KRA 2021-11-01 07640132622706 M-CATH Flexy Acrostak (Schweiz) AG KRA 2021-11-01 07640132622157 M-CATH Microcatheter Acrostak (Schweiz) AG KRA 2018-05-15 10351688507990 Medex ICU MEDICAL, INC. KRA 2016-12-30 10351688508669 Medex ICU MEDICAL, INC. KRA 2016-12-30 10351688505620 Medex ICU MEDICAL, INC. KRA 2016-12-29 10351688508768 Medex ICU MEDICAL, INC. KRA 2016-10-19 10351688508775 Medex ICU MEDICAL, INC. KRA 2016-10-19 10351688508782 Medex ICU MEDICAL, INC. KRA 2016-10-19 10351688508805 Medex ICU MEDICAL, INC. KRA 2016-10-19 10351688506856 Medex ICU MEDICAL, INC. KRA 2016-10-12 10351688506863 Medex ICU MEDICAL, INC. KRA 2016-10-12 10351688508898 Medex ICU MEDICAL, INC. KRA 2016-10-11 10351688509932 Medex ICU MEDICAL, INC. KRA 2016-10-11 08714729235118 Renegade™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729235125 Renegade™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280583 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280590 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280606 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280613 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280620 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280637 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280644 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280651 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280668 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280736 Renegade™ HI-FLO™ Kit BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280743 Renegade™ HI-FLO™ Kit BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280750 Renegade™ HI-FLO™ Kit BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280767 Renegade™ HI-FLO™ Kit BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24