GUDID 00763000239282

CONTROLLER 97745 PAIN PTM INTELLIS PAPER

MEDTRONIC, INC.

Multiple active implantable device programmer

• Primary Device ID: 00763000239282
• NIH Device Record Key: e47b4f6d-1059-4e69-b724-115ff40809e5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 97745
• 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
• 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 -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000239282 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-25
• Device Publish Date: 2019-06-17

Devices Manufactured by MEDTRONIC, INC.

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• 00763000579388 - N/A: 2025-02-18 TELEMETRY MODULE TM90Q0 ISTIM X US
• 00763000879297 - NA: 2025-02-18 TELEMETRY TM90Q0 ISTIM X US EMAN
• 00763000988777 - NA: 2025-02-17 CUSTOM PACK BB6Z71R15 VA
• 20763000998145 - NA: 2025-02-17 CUSTOM PACK SSBB12N37R 10PK LOWER LMB
• 00763000998424 - NA: 2025-02-17 CUSTOM PACK BB10Z65R1 V A D
• 00763000517830 - Hancock™: 2025-02-14 CONDUIT HC15022 HK1 MO 26L
• 00763000995775 - NA: 2025-02-14 CUSTOM PACK BB11W65R2 SPECTRUM CPB