Intellis™ AdaptiveStim®

GUDID 00763000315467

INS 97715 INTELLIS SENSOR US EMANUAL

MEDTRONIC, INC.

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• Primary Device ID: 00763000315467
• NIH Device Record Key: bb1ec692-e4f4-46e6-9050-93fc1a512515
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intellis™ AdaptiveStim®
• Version Model Number: 97715
• 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 -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
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000315467 [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™ AdaptiveStim®]

• 00643169781702: INS 97715 INTELLIS SENSOR MRI US EMANUAL
• 00763000315467: INS 97715 INTELLIS SENSOR US EMANUAL