SureTune™ 4

Primary DI
00763000990442
Brand
SureTune™ 4
Company
MEDTRONIC, INC.
Model
B36104S
Device description
SW B36104S SURETUNE4 DBS SERVER 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
00763000990442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000990442007630009904427630009904420763000990442

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
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22
00613994963819Sones™ C0087202016-06-05
00613994963833NIH™0087622016-07-24
00613994963840NIH™0087632016-06-10
00613994963987Sones™ Brachial0077702016-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000990428SureTune™ 4MEDTRONIC, INC.QQC2025-06-08
00763000990435SureTune™ 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