PRGM 37022 ENS ULTRA/ACTIVA FLEX Medical Device Identification

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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