MITRIS Handle 1140M 1140M

GUDID 00690103210132

11400M valve handle

Edwards Lifesciences LLC

Heart valve annulus sizer, reusable
Primary Device ID00690103210132
NIH Device Record Key36ae6492-4b77-4b41-9713-cdaf1790434a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMITRIS Handle 1140M
Version Model Number1140M
Catalog Number1140M
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)822-9637
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 Identifiers

Device Issuing AgencyDevice ID
GS100690103210132 [Primary]

FDA Product Code

DTJHolder, Heart-Valve, Prosthesis

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00690103210132]

Moist Heat or Steam Sterilization


[00690103210132]

Moist Heat or Steam Sterilization


[00690103210132]

Moist Heat or Steam Sterilization


[00690103210132]

Moist Heat or Steam Sterilization


[00690103210132]

Moist Heat or Steam Sterilization


[00690103210132]

Moist Heat or Steam Sterilization


[00690103210132]

Moist Heat or Steam Sterilization


[00690103210132]

Moist Heat or Steam Sterilization


[00690103210132]

Moist Heat or Steam Sterilization


[00690103210132]

Moist Heat or Steam Sterilization


[00690103210132]

Moist Heat or Steam Sterilization


[00690103210132]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-28
Device Publish Date2024-10-18

Devices Manufactured by Edwards Lifesciences LLC

00690103019063 - HEART VALVE HANDLE ACCESSORY2024-10-28 HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV
50690103019242 - DISPOSABLE HANDLE FOR VALVES/SIZERS2024-10-28 DISPOSABLE HANDLE FOR VALVES/SIZERS
00690103019339 - HEART VALVE ACCESSOR2024-10-28 HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S
00690103166989 - HEART VALVE ACCESSOR2024-10-28 MITRAL SIZER HANDLE
00690103177701 - A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 462024-10-28 RING HANDLE - EXTENDED 4"
00690103186437 - FLEXIBLE HANDLE2024-10-28 FLEXIBLE HANDLE
00690103210132 - MITRIS Handle 1140M2024-10-2811400M valve handle
00690103210132 - MITRIS Handle 1140M2024-10-28 11400M valve handle
00690103217773 - Edwards EVOQUE Loading System2024-10-11 Edwards EVOQUE Loading System

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