GUDID 00613994747044

ANTENNA 37092 SENSOR W/OUT INTERCEPT

MEDTRONIC, INC.

Active-implantable-device communicator
Primary Device ID00613994747044
NIH Device Record Keyed3dd2d2-2b76-4589-a4bd-ebe4dadaad26
Commercial Distribution StatusIn Commercial Distribution
Version Model Number37092
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 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)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

Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994747044 [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 Date2014-09-23

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