SureTune™ 4

GUDID 00763000421212

SW B36104S SURETUNE4 DBS SERVER

MEDTRONIC, INC.

Implantable electrical stimulation device management software

• Primary Device ID: 00763000421212
• NIH Device Record Key: 4bbe085f-1283-4503-a133-7da7dff4c7a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureTune™ 4
• Version Model Number: B36104S
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000421212 [Direct Marking]
GS1	00763000496432 [Primary]
GS1	00763000496449 [Primary]
GS1	00763000496456 [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: 2021-11-01
• Device Publish Date: 2021-10-22

Devices Manufactured by MEDTRONIC, INC.

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• 20763000975016 - NA: 2024-09-17 CUSTOM PACK BB10M39R3 10PK VAMP/ACC
• 00763000975197 - NA: 2024-09-17 CUSTOM PACK BB8G55R17 A PACK
• 00763000974190 - NA: 2024-09-16 CUSTOM PACK HY9L80R7 SADT FUS
• 00763000974251 - NA: 2024-09-16 CUSTOM PACK HY4D49R18 LEFT HBY
• 00763000975135 - NA: 2024-09-16 CUSTOM PACK BB12G92R4 L PEDI/S ADUL
• 00763000974572 - NA: 2024-09-10 CUSTOM PACK BB3X42R20 UNV
• 20763000181080 - NA: 2024-09-09 CABLE 5833SL SURGICAL5PK DISP