SureTune™ 4

Primary DI
00763000496449
Brand
SureTune™ 4
Company
MEDTRONIC, INC.
Model
B36104C
Device description
SW B36104C SURETUNE4 DBS CLIENT
Published
2021-10-22
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
00763000421212Direct MarkingGS10
00763000496449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000421212007630004212127630004212120763000421212
00763000496449007630004964497630004964490763000496449

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.

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
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02
00643169014121INPUT™ PS8933112017-02-02
00643169014138INPUT™ PS8833112017-02-03
00643169014145INPUT™ PS8733112017-02-03
00643169014152INPUT™ PS8633112017-02-02
00643169014169INPUT™ PS8533112017-02-02
00643169014176NA6933112016-08-20
00643169014213NA6633112017-02-02
00643169014220NA6533112017-02-02
00643169014237INPUT™ PS5933112017-02-03
00643169014244INPUT™ PS5833112017-02-02

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
00763000990442SureTune™ 4MEDTRONIC, INC.QQC2025-06-08
04056481142032Brainlab Elements Guide XT, Guide 3.0Brainlab SEQQC2022-04-27
00763000496432SureTune™ 4MEDTRONIC, INC.QQC2021-10-22
00763000496456SureTune™ 4MEDTRONIC, INC.QQC2021-10-22
00763000421212SureTune™ 4MEDTRONIC, INC.QQC2021-10-22