Eon™ 1111

GUDID 05415067019509

ST. JUDE MEDICAL, INC.

Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug
Primary Device ID05415067019509
NIH Device Record Keyd03d735f-7c2a-4ae0-949c-104c15027b4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEon™
Version Model Number1111
Catalog Number1111
Company DUNS149818952
Company NameST. JUDE MEDICAL, 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 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(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal
Storage Environment Atmospheric PressureBetween 0.07 KiloPascal and 0.15 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067019509 [Primary]
GS115415067019506 [Package]
Package: [5 Units]
Discontinued: 2020-05-13
Not in Commercial Distribution

FDA Product Code

LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-03-17

On-Brand Devices [Eon™]

15415067030273Port Plug
054150670195091111
054147344054303728
05414734405416Charger Accesory
054147344054093726
154147344000981111

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