26F (8.6MM) X 25CM ASCENDRA+ INTRODUCER SHEATH SET 9350IS29A

GUDID 00690103193763

ASCENDRA+ INTRODUCER SHEATH SET

Edwards Lifesciences LLC

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Primary Device ID00690103193763
NIH Device Record Key13b9661a-f0a5-4d45-903d-15787c6e0923
Commercial Distribution StatusIn Commercial Distribution
Brand Name26F (8.6MM) X 25CM ASCENDRA+ INTRODUCER SHEATH SET
Version Model Number9350IS29
Catalog Number9350IS29A
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
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

Customer Support Contacts

Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100690103193763 [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 Number4
Public Version Date2019-06-07
Device Publish Date2014-08-30

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00690103218855 - HemoSphere Vita2024-03-05 HemoSphere Vita Monitor
00690103218862 - HemoSphere Vita2024-03-05 Vita Technology Module
50690103218898 - VitaWave2024-02-28 VitaWave Finger Cuff Adult
00690103217483 - EVOQUE2024-02-15 Edwards EVOQUE Stabilizer Plate
00690103217490 - EVOQUE2024-02-15 Edwards EVOQUE Loading System
00690103217506 - EVOQUE2024-02-15 Edwards EVOQUE Dilator Kit (24, 28, 33 Fr dilators)

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