SAPIEN 3 Ultra RESILIA 9755RSL26A

GUDID 00690103215816

SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 26mm

Edwards Lifesciences LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework
Primary Device ID00690103215816
NIH Device Record Keyf81c6229-d56e-49cf-a2f6-4f4f7b38196e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAPIEN 3 Ultra RESILIA
Version Model Number9755RSL26
Catalog Number9755RSL26A
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103215816 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-02
Device Publish Date2022-08-25

On-Brand Devices [SAPIEN 3 Ultra RESILIA ]

00690103215823SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 29mm
00690103215816SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 26mm
00690103215809SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 23mm
00690103215793SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 20mm

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