Axela Sheath 9630ES14A

GUDID 00690103200782

Axela Sheath (US)

Edwards Lifesciences LLC

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Primary Device ID00690103200782
NIH Device Record Key2a477475-5e94-4801-b384-72c92520a88f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxela Sheath
Version Model Number9630ES14A
Catalog Number9630ES14A
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 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

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103200782 [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 Number2
Public Version Date2019-06-07
Device Publish Date2019-01-10

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