GUDID 00613994348661

ANTENNA 37092 EXT ULTRA US MKT

MEDTRONIC, INC.

Active-implantable-device communicator
Primary Device ID00613994348661
NIH Device Record Key0a16bde7-2363-4214-950f-9e68aacae6e5
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 Fahrenheit and 150 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994348661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHYSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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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