Intellis™ Pro

GUDID 00763000558826

INS 977118 INTELLIS PRO US EMAN

MEDTRONIC, INC.

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

• Primary Device ID: 00763000558826
• NIH Device Record Key: 9968ec89-31cb-4fc1-a14a-3ee6a599823f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intellis™ Pro
• Version Model Number: 977118
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000558826 [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: 2024-05-13
• Device Publish Date: 2024-05-05

Devices Manufactured by MEDTRONIC, INC.

• 00199150000012 - NA: 2025-03-07 CUSTOM PACK BB10J80R7 1/4CNTRI
• 00763000997984 - NA: 2025-03-07 CUSTOM PACK BB11F56R9 PEDS V
• 00763000999346 - NA: 2025-03-07 CUSTOM PACK BB3R67R6 SU AVLOOP
• 20763000999364 - NA: 2025-03-07 CUSTOM PACK BB8A42R1 2PK TAVR PACK
• 20763000999388 - NA: 2025-03-07 CUSTOM PACK BB3J83R2 5PK 38X332X16
• 20763000999401 - NA: 2025-03-07 CUSTOM PACK BB11J01R1 5PK BRIDGE SUP
• 00763000999513 - NA: 2025-03-07 CUSTOM PACK BB11F41R3 ADLT SUPP PAC
• 20763000999777 - NA: 2025-03-07 CUSTOM PACK BB12M84R1 10PK 3/8 SUPP LINE