EDWARDS INTUITY ELITE DELIVERY SYSTEM 8300DB25

GUDID 00690103192575

EDWARDS INTUITY ELITE DELIVERY SYSTEM

Edwards Lifesciences LLC

Cardiac valvuloplasty catheter
Primary Device ID00690103192575
NIH Device Record Key061f3ac3-5e73-4c43-88e6-33846fef7eaa
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDWARDS INTUITY ELITE DELIVERY SYSTEM
Version Model Number8300DB25
Catalog Number8300DB25
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103192575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWRheart-valve, non-allograft tissue

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 Date2016-09-02

On-Brand Devices [EDWARDS INTUITY ELITE DELIVERY SYSTEM]

00690103192582EDWARDS INTUITY ELITE DELIVERY SYSTEM
00690103192575EDWARDS INTUITY ELITE DELIVERY SYSTEM
00690103192568EDWARDS INTUITY ELITE DELIVERY SYSTEM
00690103192551EDWARDS INTUITY ELITE DELIVERY SYSTEM
00690103192544EDWARDS INTUITY ELITE DELIVERY SYSTEM

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