VexPander®

GUDID 06934184001970

Dongguan TT Medical, Inc.

Coronary angioplasty balloon catheter, basic
Primary Device ID06934184001970
NIH Device Record Key7d286c67-ac2c-4864-a48d-d7c169abdce6
Commercial Distribution StatusIn Commercial Distribution
Brand NameVexPander®
Version Model NumberNC35026
Company DUNS551476865
Company NameDongguan TT Medical, Inc.
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
GS106934184001970 [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 Date2024-08-02
Device Publish Date2024-07-25

On-Brand Devices [VexPander®]

06934184010545NC40030
06934184010491NC40010
06934184002144NC40038
06934184002137NC40034
06934184002120NC40026
06934184002113NC40022
06934184002106NC40018
06934184002090NC40014
06934184002083NC37538
06934184002076NC37534
06934184002069NC37530
06934184002052NC37526
06934184002045NC37522
06934184002038NC37518
06934184002021NC37514
06934184002014NC37510
06934184002007NC35038
06934184001994NC35034
06934184001987NC35030
06934184001970NC35026
06934184001963NC35022
06934184001956NC35018
06934184001949NC35014
06934184001932NC35010
06934184001925NC32538
06934184001918NC32534
06934184010279NC30018
06934184010064NC20030
06934184010019NC20010
06934184001901NC32530
06934184001895NC32526
06934184001888NC32522
06934184001871NC32518
06934184001864NC32514
06934184001857NC32510
06934184001840NC30038
06934184001833NC30034
06934184001826NC30030
06934184001819NC30026
06934184001802NC30022
06934184001796NC30014
06934184001789NC30010
06934184001772NC27538
06934184001765NC27534
06934184001758NC27530
06934184001741NC27526
06934184001734NC27522
06934184001727NC27518
06934184001710NC27514
06934184001703NC27510

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