GUDID 00643169632080

PROG 3537FA PAT ISTM TST STM CONT US FA

MEDTRONIC, INC.

Sacral plexus percutaneous incontinence-control electrical stimulation system programmer
Primary Device ID00643169632080
NIH Device Record Key8a074d17-67e3-4f5b-b27a-836513674beb
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3537FA
Company DUNS796986144
Company NameMEDTRONIC, INC.
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169632080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZWStimulator, electrical, implantable, for incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-02

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