Intellis™

GUDID 00763000315474

INS 97716 INTELLIS US EMANUAL

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system pulse generator, implantable

• Primary Device ID: 00763000315474
• NIH Device Record Key: 32e523dc-651c-4a8f-bc27-04d2924be689
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intellis™
• Version Model Number: 97716
• Company DUNS: 796986144
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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
• 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 -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000315474 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-06
• Device Publish Date: 2020-09-28

On-Brand Devices [Intellis™]

• 00643169781740: INS 97716 INTELLIS US EMANUAL
• 00763000315474: INS 97716 INTELLIS US EMANUAL
• 00763000849061: INS 97716 INTELLIS US EMAN CARDIO