Selethru PTCA Balloon Dilatation Catheter

GUDID 06971591762339

Kossel Medtech (Suzhou) Co., Ltd.

Coronary angioplasty balloon catheter, perfusing Coronary angioplasty balloon catheter, perfusing Coronary angioplasty balloon catheter, perfusing
Primary Device ID06971591762339
NIH Device Record Key23d731db-0bb9-49e5-bc36-d3e040ed4693
Commercial Distribution StatusIn Commercial Distribution
Brand NameSelethru PTCA Balloon Dilatation Catheter
Version Model NumberKPTCA225015
Company DUNS560219894
Company NameKossel Medtech (Suzhou) 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971591762339 [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 Date2020-05-25
Device Publish Date2020-05-15

On-Brand Devices [Selethru PTCA Balloon Dilatation Catheter]

06971591762667KPTCA400030
06971591762650KPTCA400025
06971591762643KPTCA400020
06971591762636KPTCA400015
06971591762629KPTCA400010
06971591762612KPTCA350030
06971591762605KPTCA350025
06971591762599KPTCA350020
06971591762582KPTCA350015
06971591762575KPTCA350010
06971591762568KPTCA325030
06971591762551KPTCA325025
06971591762544KPTCA325020
06971591762537KPTCA325015
06971591762520KPTCA325010
06971591762513KPTCA300030
06971591762506KPTCA300025
06971591762490KPTCA300020
06971591762483KPTCA300015
06971591762476KPTCA300010
06971591762469KPTCA275030
06971591762452KPTCA275025
06971591762445KPTCA275020
06971591762438KPTCA275015
06971591762421KPTCA275010
06971591762414KPTCA250030
06971591762407KPTCA250025
06971591762391KPTCA250020
06971591762384KPTCA250015
06971591762377KPTCA250010
06971591762360KPTCA225030
06971591762353KPTCA225025
06971591762346KPTCA225020
06971591762339KPTCA225015
06971591762322KPTCA225010
06971591762315KPTAC200030
06971591762308KPTCA200025
06971591762292KPTCA200020
06971591762285KPTCA200015
06971591762278KPTCA200010
06971591762261KPTCA150030
06971591762247KPTCA150020
06971591762230KPTCA150015
06971591762162KPTCA150010

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