Minerva PTA Balloon Dilatation Catheter 803-045200-090U

GUDID 06958481418125

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic
Primary Device ID06958481418125
NIH Device Record Key7c39d2d4-0d04-4281-ac52-c785a184b994
Commercial Distribution StatusIn Commercial Distribution
Brand NameMinerva PTA Balloon Dilatation Catheter
Version Model Numberrev 01
Catalog Number803-045200-090U
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
GS106958481418125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, Angioplasty, Peripheral, Transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-31

On-Brand Devices [Minerva PTA Balloon Dilatation Catheter]

06958481419962rev 01
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06958481419474rev 01

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