A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46 1151

GUDID 00690103177701

RING HANDLE - EXTENDED 4"

Edwards Lifesciences LLC

Heart valve prosthesis holder, reusable
Primary Device ID00690103177701
NIH Device Record Keyeff17967-9916-42e3-9c63-31245944540c
Commercial Distribution StatusIn Commercial Distribution
Brand NameA HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46
Version Model Number1151
Catalog Number1151
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 Datefalse
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103177701 [Primary]

FDA Product Code

DTJHolder, Heart-Valve, Prosthesis

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00690103177701]

Moist Heat or Steam Sterilization


[00690103177701]

Moist Heat or Steam Sterilization


[00690103177701]

Moist Heat or Steam Sterilization


[00690103177701]

Moist Heat or Steam Sterilization


[00690103177701]

Moist Heat or Steam Sterilization


[00690103177701]

Moist Heat or Steam Sterilization


[00690103177701]

Moist Heat or Steam Sterilization


[00690103177701]

Moist Heat or Steam Sterilization


[00690103177701]

Moist Heat or Steam Sterilization


[00690103177701]

Moist Heat or Steam Sterilization


[00690103177701]

Moist Heat or Steam Sterilization


[00690103177701]

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

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00690103216998 - HEMOSPHERE2025-07-23 Mindray OEM Pressure Smart Cable
00690103219111 - Cable2025-07-23 PHILIPS CARDIAC OUTPUT TEMPERATURE PROBE
07460691949867 - PRESSURE MONITORING ACCESSORY2025-07-23 PRESSURE MONITORING ACCESSORY
57460691956143 - TruWave2025-07-23 PRESSURE MONITORING ACCESSORY

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