SureTune™ 4

Primary DI
00763000496456
Brand
SureTune™ 4
Company
MEDTRONIC, INC.
Model
B36104S
Device description
SW B36104S SURETUNE4 DBS SERVER
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
00763000496456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000421212007630004212127630004212120763000421212
00763000496456007630004964567630004964560763000496456

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
00199150070114NAC320LBBL452026-04-13
00199150070121NAC320LBBL482026-04-13
00199150070138NAC320LBBS452026-04-13
00199150070145NAC320LBBS482026-04-13
00613994764546SHERPA NX BALANCEDSB8JR4052016-07-31
00613994764577SHERPA NX BALANCEDSB8JR3552016-07-31
00613994765055SHERPA NX BALANCEDSB8JL5052016-07-31
00613994765116SHERPA NX BALANCEDSB8JL4052016-07-31
00613994765147SHERPA NX BALANCEDSB8JL3552016-07-31
00613994766458SHERPA NX BALANCEDSB8AL1052016-06-12
00613994766526SHERPA NX BALANCEDSB8AR2052016-06-12
00613994766557SHERPA NX BALANCEDSB8AR1052016-06-12
00613994767158SHERPA NX BALANCEDSB8EBU4552016-06-12
00613994767196SHERPA NX BALANCEDSB8EBU4052016-06-12
00613994767240SHERPA NX BALANCEDSB8EBU3552016-06-12
00613994768018LauncherLA8JL5052016-04-08
00613994768124LauncherLA8JL4052016-04-15
00613994768308LauncherLA8JR4052016-09-01
00613994768353LauncherLA8JR3552016-04-07
00613994769497LauncherLA8AR2052016-04-16

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
00763000496449SureTune™ 4MEDTRONIC, INC.QQC2021-10-22
00763000421212SureTune™ 4MEDTRONIC, INC.QQC2021-10-22