CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER 1173R29

GUDID 00690103186338

CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE

Edwards Lifesciences LLC

Heart valve annulus sizer, reusable
Primary Device ID00690103186338
NIH Device Record Keyd6a81433-6e1d-4930-9432-e28525cd1170
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER
Version Model Number1173R
Catalog Number1173R29
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)822-9837
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 Identifiers

Device Issuing AgencyDevice ID
GS100690103186338 [Primary]

FDA Product Code

DTISizer, Heart-Valve, Prosthesis

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00690103186338]

Moist Heat or Steam Sterilization


[00690103186338]

Moist Heat or Steam Sterilization


[00690103186338]

Moist Heat or Steam Sterilization


[00690103186338]

Moist Heat or Steam Sterilization


[00690103186338]

Moist Heat or Steam Sterilization


[00690103186338]

Moist Heat or Steam Sterilization


[00690103186338]

Moist Heat or Steam Sterilization


[00690103186338]

Moist Heat or Steam Sterilization


[00690103186338]

Moist Heat or Steam Sterilization


[00690103186338]

Moist Heat or Steam Sterilization


[00690103186338]

Moist Heat or Steam Sterilization


[00690103186338]

Moist Heat or Steam Sterilization


[00690103186338]

Moist Heat or Steam Sterilization


[00690103186338]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-18
Device Publish Date2026-02-10

On-Brand Devices [CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER]

00690103186352CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
00690103186345CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
00690103186338CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
00690103186314CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.