POT PTCA Balloon Dilatation Catheter 833-5008

GUDID 06958481438680

BrosMed Medical Co.,Ltd.

Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic
Primary Device ID06958481438680
NIH Device Record Key93e20f3b-f2dc-487d-92f4-e196d157f16f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOT PTCA Balloon Dilatation Catheter
Version Model Numberrev01
Catalog Number833-5008
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
GS106958481438680 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-16
Device Publish Date2023-05-08

On-Brand Devices [POT PTCA Balloon Dilatation Catheter]

06958481438802rev01
06958481438796rev01
06958481438789rev01
06958481438772rev01
06958481438765rev01
06958481438758rev01
06958481438741rev01
06958481438734rev01
06958481438727rev01
06958481438710rev01
06958481438703rev01
06958481438697rev01
06958481438680rev01
06958481438673rev01
06958481438666rev01
06958481438659rev01
06958481438642rev01
06958481438635rev01
06958481438628rev01
06958481438611rev01
06958481438604rev01
06958481438598rev01
06958481438581rev01
06958481438574rev01
06958481438567rev01
06958481438550rev01
06958481438543rev01
06958481438536rev01
06958481438529rev01
06958481438512rev01
06958481438505rev01
06958481438499rev01
06958481438482rev01
06958481438475rev01
06958481438468rev01
06958481438451rev01
06958481438444rev01
06958481438437rev01
06958481438420rev01
06958481438413rev01
06958481438406rev01
06958481438390rev01
06958481438383rev01
06958481438376rev01
06958481438369rev01
06958481438352rev01
06958481438345rev01
06958481438338rev01
06958481438321rev01

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