CoreValve™

GUDID 00643169565630

DEL SYS DCS-C4-18F-23US COM 23 NP

MEDTRONIC COREVALVE LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework
Primary Device ID00643169565630
NIH Device Record Key48886f93-2f6d-40a2-b863-aa68799a105a
Commercial Distribution Discontinuation2017-08-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCoreValve™
Version Model NumberDCS-C4-18F-23US
Company DUNS079527231
Company NameMEDTRONIC COREVALVE LLC
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100643169565630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPTAortic valve, prosthesis, percutaneously delivered

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 Date2015-08-06

On-Brand Devices [CoreValve™]

00643169565630DEL SYS DCS-C4-18F-23US COM 23 NP
00643169565623DEL SYS DCS-C4-18F-US COM 26/29/31 NP
00643169448186DELIV SYS DCS-C4-18F-US US COMM 26/29/31
00643169448179DELIV SYS DCS-C4-18F-23US US COMM 23
00643169448162COMP LOADING SYS CLS-3000-18F-US US COMM
00643169434301COMPRESSION LOADING SYSTEM CLS-3000-18FR
00643169432376DELIV SYS DCS-C4-18FR-23 ACCUTRAK 23
00643169432369DELIV SYS DCS-C4-18FR ACCUTRAK 26/29/31

Trademark Results [CoreValve]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COREVALVE
COREVALVE
77418215 3688088 Live/Registered
MEDTRONIC CV LUXEMBOURG S.A.R.L.
2008-03-10
COREVALVE
COREVALVE
77243631 3405124 Live/Registered
MEDTRONIC CV LUXEMBOURG S.A.R.L.
2007-07-31

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