SureTune™ 4

GUDID 00763000421212

SW B36104S SURETUNE4 DBS SERVER

MEDTRONIC, INC.

Implantable electrical stimulation device management software
Primary Device ID00763000421212
NIH Device Record Key4bbe085f-1283-4503-a133-7da7dff4c7a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSureTune™ 4
Version Model NumberB36104S
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000421212 [Direct Marking]
GS100763000496432 [Primary]
GS100763000496449 [Primary]
GS100763000496456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QQCBrain stimulation programming planning software.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-01
Device Publish Date2021-10-22

Devices Manufactured by MEDTRONIC, INC.

20199150023800 - NA2025-06-09 CUSTOM PACK BB11X70R1 5PK AV LOOP
20199150023824 - NA2025-06-09 CUSTOM PACK BB8A44R4 4PK HBC MYO
20199150024135 - NA2025-06-09 CUSTOM PACK BB11A07R2 5PK BRIDGE LINE
00613994163523 - Duran AnCore2025-06-09 TOOL 7620HXL HANDLE DURAN ANCORE 14L
00613994959546 - Open Pivot™2025-06-09 ACCY 558 ACTUATOR PACKAGE AVG
00643169402539 - MOSAIC ULTRA™2025-06-09 SIZERS 7308U MOSAIC ULTRA AORTIC 26L
00643169402591 - MOSAIC™CINCH™2025-06-09 SIZERS 7308C MOSAIC CINCH AORTIC 26L
00643169525511 - CG Future™2025-06-09 SIZER SET 7638S CG FUTURE 26L

Trademark Results [SureTune]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURETUNE
SURETUNE
97101989 not registered Live/Pending
Medtronic Bakken Research Center B.V.
2021-11-01
SURETUNE
SURETUNE
88110798 not registered Live/Pending
Medtronic Bakken Research Center B.V.
2018-09-10
SURETUNE
SURETUNE
85521008 4209278 Dead/Cancelled
Sapiens Steering Brain Stimulation B.V.
2012-01-20

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.