Direxion™ HI-FLO™

GUDID 08714729839569

Torqueable Microcatheter

BOSTON SCIENTIFIC CORPORATION

Vascular microcatheter
Primary Device ID08714729839569
NIH Device Record Key17a3320d-8c86-44cf-a2ea-1ad3c3aaccca
Commercial Distribution Discontinuation2021-08-29
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDirexion™ HI-FLO™
Version Model NumberM001195490
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS108714729839569 [Primary]

FDA Product Code

KRACatheter, continuous flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-09-25
Device Publish Date2016-09-24

On-Brand Devices [Direxion™ HI-FLO™]

08714729839569Torqueable Microcatheter
08714729839538Torqueable Microcatheter

Trademark Results [Direxion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIREXION
DIREXION
85717234 4515484 Live/Registered
Boston Scientific Scimed, Inc.
2012-08-30
DIREXION
DIREXION
77617332 3642901 Live/Registered
Rafferty Asset Management, LLC
2008-11-19

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