EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS29A

GUDID 00690103194166

EDWARDS CERTITUDE DELIVERY SYSTEM

Edwards Lifesciences 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 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 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 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 ID00690103194166
NIH Device Record Keyc8b2db8d-88aa-4a6f-9017-0ea2fe89a793
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDWARDS CERTITUDE DELIVERY SYSTEM
Version Model Number9600SDS29
Catalog Number9600SDS29A
Company DUNS134139174
Company NameEdwards Lifesciences 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
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Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
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Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *COOL, DRY PLACE.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103194166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPUProsthesis, Mitral Valve, 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 Date2017-01-09

On-Brand Devices [EDWARDS CERTITUDE DELIVERY SYSTEM]

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