Polux PTA Balloon Dilatation Catheter 818-055030-150U

GUDID 06958481445411

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic
Primary Device ID06958481445411
NIH Device Record Key148b3750-5e42-435e-bb1b-b28ed92e5eda
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolux PTA Balloon Dilatation Catheter
Version Model Numberrev 01
Catalog Number818-055030-150U
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
GS106958481445411 [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 [Polux PTA Balloon Dilatation Catheter]

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