SureTune™ 4

GUDID 00763000990428

SW B36104A SURETUNE4 DBS STANDALONE MDR

MEDTRONIC, INC.

Implantable electrical stimulation device management software

• Primary Device ID: 00763000990428
• NIH Device Record Key: 63e99512-c284-48ac-9260-879004746b90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureTune™ 4
• Version Model Number: B36104A
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000990428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN210003

FDA Product Code

• QQC: Brain stimulation programming planning software.

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: 2025-06-16
• Device Publish Date: 2025-06-08

On-Brand Devices [SureTune™ 4]

• 00763000421212: SW B36104S SURETUNE4 DBS SERVER
• 00763000990442: SW B36104S SURETUNE4 DBS SERVER MDR
• 00763000990435: SW B36104C SURETUNE4 DBS CLIENT MDR
• 00763000990428: SW B36104A SURETUNE4 DBS STANDALONE MDR