FUBUKI XF

GUDID 04547327142724

ASAHI INTECC CO., LTD.

Vascular guide-catheter, single-use
Primary Device ID04547327142724
NIH Device Record Keyddcd06eb-bb14-4c4b-960a-fbfaafdcd70c
Commercial Distribution StatusIn Commercial Distribution
Brand NameFUBUKI XF
Version Model NumberFBKX-8S80DY
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

Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French
Length80 Centimeter
Catheter Gauge6 French

Device Identifiers

Device Issuing AgencyDevice ID
GS104547327142724 [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 Date2022-04-06
Device Publish Date2022-03-29

On-Brand Devices [FUBUKI XF]

04547327142793FBKX-8A110DY
04547327142786FBKX-8S110DY
04547327142779FBKX-8A100DY
04547327142762FBKX-8S100DY
04547327142755FBKX-8A90DY
04547327142748FBKX-8S90DY
04547327142731FBKX-8A80DY
04547327142724FBKX-8S80DY

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.