GUDID 00643169585928

CHARGING SYS 97754 INSR MRICS 60601-1-11

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger

• Primary Device ID: 00643169585928
• NIH Device Record Key: 8fa6a694-3035-480f-97ad-210182456b2e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 97754
• 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

• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169585928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P840001

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: 2015-09-18

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