HEART VALVE HANDLE ACCESSORY 1111

GUDID 00690103019063

HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV

Edwards Lifesciences LLC

Heart valve prosthesis holder, reusable
Primary Device ID00690103019063
NIH Device Record Keyaba2ada6-c410-4462-84b8-54427b840452
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEART VALVE HANDLE ACCESSORY
Version Model Number1111
Catalog Number1111
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 Perscriptionfalse
OTC Over-The-Countertrue

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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, cool place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103019063 [Primary]

FDA Product Code

DTJHolder, Heart-Valve, Prosthesis

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00690103019063]

Moist Heat or Steam Sterilization


[00690103019063]

Moist Heat or Steam Sterilization


[00690103019063]

Moist Heat or Steam Sterilization


[00690103019063]

Moist Heat or Steam Sterilization


[00690103019063]

Moist Heat or Steam Sterilization


[00690103019063]

Moist Heat or Steam Sterilization


[00690103019063]

Moist Heat or Steam Sterilization


[00690103019063]

Moist Heat or Steam Sterilization


[00690103019063]

Moist Heat or Steam Sterilization


[00690103019063]

Moist Heat or Steam Sterilization


[00690103019063]

Moist Heat or Steam Sterilization


[00690103019063]

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

00690103219494 - Edwards Reusable Rail Extension2025-07-17 Edwards Reusable Rail Extension
00690103219500 - Edwards Reusable Rail2025-07-17 Edwards Reusable Rail
00690103219562 - Edwards EVOQUE Loading System2025-07-17 Edwards EVOQUE Loading System
00690103219579 - Edwards EVOQUE Stabilizer 2025-07-17 Edwards EVOQUE Stabilizer
00690103220001 - Edwards rail tray2025-07-17 Edwards rail tray
00690103220629 - ESHEATH OPTIMA INTRODUCER SET (14F)2025-05-15 eSheath Optima Introducer Set (14F)
00690103217957 - HemoSphere Alta2025-03-21 HemoSphere Alta advanced monitor (All-on-one)
00690103217964 - HemoSphere Alta2025-03-21 HemoSphere Alta advanced monitor (Smart Recovery)

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