MTS™ 3510

GUDID 05414734402392

ST. JUDE MEDICAL, INC.

Analgesic spinal cord electrical stimulation system Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

• Primary Device ID: 05414734402392
• NIH Device Record Key: b82ddb22-cbc6-4dea-a8fe-774a160efb1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MTS™
• Version Model Number: 3510
• Catalog Number: 3510
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734402392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033757

FDA Product Code

• GZB: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-04-25

On-Brand Devices [MTS™]

• 05414734402392: 3510
• 05414734400596: 1183