SureTune™ 4

Primary DI
00763000990428
Brand
SureTune™ 4
Company
MEDTRONIC, INC.
Model
B36104A
Device description
SW B36104A SURETUNE4 DBS STANDALONE MDR
Published
2025-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QQCBrain stimulation programming planning software.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQCBrain Stimulation Programming Planning Software.Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN210003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN210003000SureTune4 SoftwareMedtronic Neuromodulation2021-08-23QQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000990428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000990428007630009904287630009904280763000990428

GMDN Terms#

Term, Definition table
TermDefinition
Implantable electrical stimulation device management softwareA software program intended to assist with the management of an implantable electrical stimulator associated with stimulation of the spinal cord, non-auditory peripheral nerves, brain, and/or muscles; it is not intended to manage hearing assistive implants. It may be intended for use in one or more areas of functionality including: 1) configuration of a variety of electrical pulse parameters (e.g., amplitude, frequency, width) for the provision of periodic electrical stimulation; 2) post-implantation visualization; 3) assessment of programming parameters; 4) collection of patient clinical data.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000990435SureTune™ 4MEDTRONIC, INC.QQC2025-06-08
00763000990442SureTune™ 4MEDTRONIC, INC.QQC2025-06-08
04056481142032Brainlab Elements Guide XT, Guide 3.0Brainlab SEQQC2022-04-27
00763000496432SureTune™ 4MEDTRONIC, INC.QQC2021-10-22
00763000496449SureTune™ 4MEDTRONIC, INC.QQC2021-10-22
00763000496456SureTune™ 4MEDTRONIC, INC.QQC2021-10-22
00763000421212SureTune™ 4MEDTRONIC, INC.QQC2021-10-22