GUDID 00613994972286

PRGM 37022 ENS ULTRA/ACTIVA FLEX

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system 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

• Primary Device ID: 00613994972286
• NIH Device Record Key: 07cc2eff-3f1c-459c-a690-d5c1b8c84df8
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 37022
• Company DUNS: 796986144
• Company Name: MEDTRONIC, 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994972286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H020007

FDA Product Code

• NHL: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2014-09-23

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