Edwards EVOQUE Loading System 9850LSAUS

GUDID 00690103217773

Edwards EVOQUE Loading System

Edwards Lifesciences LLC

Vascular catheter introduction set, nonimplantable
Primary Device ID00690103217773
NIH Device Record Key8879d689-d00d-4952-bb57-8240754c48a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdwards EVOQUE Loading System
Version Model Number9850LSAUS
Catalog Number9850LSAUS
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
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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
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
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 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103217773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPWPercutaneously Delivered Prostheses And Tricuspid Valves

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


[00690103217773]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-11
Device Publish Date2024-10-03

On-Brand Devices [Edwards EVOQUE Loading System]

00690103217773Edwards EVOQUE Loading System
00690103219562Edwards EVOQUE Loading System

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