Artimes Balloon Dilatation Catheter 801-1705U

GUDID 06958481412062

BrosMed Medical Co.,Ltd.

Coronary angioplasty balloon catheter, basic
Primary Device ID06958481412062
NIH Device Record Key318a024d-af74-44f0-9e4e-b3409eb1ecd2
Commercial Distribution StatusIn Commercial Distribution
Brand NameArtimes Balloon Dilatation Catheter
Version Model Numberrev 01
Catalog Number801-1705U
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
GS106958481412062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2016-09-10

On-Brand Devices [Artimes Balloon Dilatation Catheter]

06958481412505rev 01
06958481412499rev 01
06958481412482rev 01
06958481412475rev 01
06958481412468rev 01
06958481412451rev 01
06958481412444rev 01
06958481412437rev 01
06958481412420rev 01
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06958481412406rev 01
06958481412390rev 01
06958481412383rev 01
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06958481412369rev 01
06958481412352rev 01
06958481412345rev 01
06958481412338rev 01
06958481412321rev 01
06958481412314rev 01
06958481412307rev 01
06958481412291rev 01
06958481412284rev 01
06958481412277rev 01
06958481412260rev 01
06958481412253rev 01
06958481412246rev 01
06958481412239rev 01
06958481412222rev 01
06958481412215rev 01
06958481412208rev 01
06958481412192rev 01
06958481412185rev 01
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06958481412161rev 01
06958481412154rev 01
06958481412147rev 01
06958481412130rev 01
06958481412123rev 01
06958481412116rev 01
06958481412109rev 01
06958481412093rev 01
06958481412086rev 01
06958481412079rev 01
06958481412062rev 01
06958481412055rev 01
06958481412048rev 01
06958481412031rev 01
06958481412024rev 01
06958481412017rev 01

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