EDWARDS CRIMPER 9350CRA

GUDID 00690103192063

Edwards Lifesciences LLC

Basic crimper Basic crimper
Primary Device ID00690103192063
NIH Device Record Key344bf84f-3bc9-440f-bff1-a88ea94f9a4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDWARDS CRIMPER
Version Model Number9350CR
Catalog Number9350CRA
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103192063 [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 Number3
Public Version Date2018-07-06
Device Publish Date2014-08-30

On-Brand Devices [EDWARDS CRIMPER]

006901031983319600CR
006901031939789600CR
006901031920639350CR

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