FUBUKI XF-R

GUDID 04547327161794

ASAHI INTECC CO., LTD.

Vascular guide-catheter, single-use
Primary Device ID04547327161794
NIH Device Record Keya41c8569-453b-4522-b97d-d1c9edf2d03f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFUBUKI XF-R
Version Model NumberFBKR-8S95DY
Company DUNS690711189
Company NameASAHI INTECC CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Device Dimensions

Length95 Centimeter
Catheter Gauge6 French
Length95 Centimeter
Catheter Gauge6 French
Length95 Centimeter
Catheter Gauge6 French
Length95 Centimeter
Catheter Gauge6 French
Length95 Centimeter
Catheter Gauge6 French
Length95 Centimeter
Catheter Gauge6 French
Length95 Centimeter
Catheter Gauge6 French
Length95 Centimeter
Catheter Gauge6 French
Length95 Centimeter
Catheter Gauge6 French
Length95 Centimeter
Catheter Gauge6 French
Length95 Centimeter
Catheter Gauge6 French
Length95 Centimeter
Catheter Gauge6 French
Length95 Centimeter
Catheter Gauge6 French

Device Identifiers

Device Issuing AgencyDevice ID
GS104547327161794 [Primary]

FDA Product Code

QJPCatheter, Percutaneous, Neurovasculature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-31
Device Publish Date2025-07-23

On-Brand Devices [FUBUKI XF-R]

04547327161800FBKR-8S100DY
04547327161794FBKR-8S95DY
04547327161787FBKR-8S90DY
04547327161770FBKR-8S80DY

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