GUDID 00763000239305

CONTROLLER 97745 INTELLIS PTM FA

MEDTRONIC, INC.

Multiple active implantable device programmer

• Primary Device ID: 00763000239305
• NIH Device Record Key: bec12071-0138-4863-8310-66801ac0dcc3
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 97745FA
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000239305 [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: 2019-07-02
• Device Publish Date: 2019-06-24

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• 00763000764951 - NA: 2026-04-01 CUSTOM PACK BB12A73R AV LOOP
• 00763000770419 - NA: 2026-04-01 CUSTOM PACK 11Z79R1 VALVE SK LN
• 00763000770433 - NA: 2026-04-01 CUSTOM PACK BB12B18R HIIT FUS
• 00763000774127 - NA: 2026-04-01 CUSTOM PACK BB11U49R3 ADULT QUANTUM
• 00763000791421 - NA: 2026-04-01 CUSTOM PACK BB11Y57R5 HEART LUNG