Artime Balloon Dilatation Catheter 801-3725U

GUDID 06958481487497

BrosMed Medical Co.,Ltd.

Coronary angioplasty balloon catheter, basic
Primary Device ID06958481487497
NIH Device Record Key8397c7dc-c3c0-463e-89ce-41c966605aa7
Commercial Distribution StatusIn Commercial Distribution
Brand NameArtime Balloon Dilatation Catheter
Version Model Numberrev01
Catalog Number801-3725U
Company DUNS421318800
Company NameBrosMed Medical 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106958481487497 [Primary]

FDA Product Code

LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-01
Device Publish Date2024-12-24

On-Brand Devices [Artime Balloon Dilatation Catheter]

06958481487558rev01
06958481487541rev01
06958481487534rev01
06958481487527rev01
06958481487510rev01
06958481487503rev01
06958481487497rev01
06958481487480rev01
06958481487473rev01
06958481487466rev01
06958481487459rev01
06958481487442rev01
06958481487435rev01
06958481487428rev01
06958481487411rev01
06958481487404rev01
06958481487398rev01
06958481487381rev01
06958481487374rev01
06958481487367rev01
06958481487350rev01
06958481487343rev01
06958481487336rev01
06958481487329rev01
06958481487312rev01
06958481487305rev01
06958481432718rev01
06958481432701rev01
06958481432695rev01
06958481432688rev01
06958481432640rev01
06958481432633rev01
06958481432626rev01
06958481428209rev01
06958481428193rev01
06958481428186rev01
06958481428179rev01
06958481428162rev01

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.