FDA.reportPublic FDA data

Sprint Quattro Secure S MRI™ SureScan™

Primary DI
00763000180126
Brand
Sprint Quattro Secure S MRI™ SureScan™
Company
MEDTRONIC, INC.
Model
6935M62
Device description
LEAD 6935M62 MRI US DF4 RCMCRD
Published
2024-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTBpermanent pacemaker Electrode
NVYPermanent defibrillator electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTBPermanent Pacemaker ElectrodeCardiovascular3
NVYPermanent Defibrillator ElectrodesUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000180126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000180126007630001801267630001801260763000180126

GMDN Terms#

Term, Definition table
TermDefinition
Endocardial defibrillation leadAn implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length62Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature77 Degrees Fahrenheit77 Degrees Fahrenheit

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
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.NVY2023-11-02
04035479157821EFH-6F-WBIOTRONIK SE & Co. KGDTB2017-11-22
04035479157838EFH-6F-WBIOTRONIK SE & Co. KGDTB2017-11-17
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169453180CapSureFix™ NovusMEDTRONIC, INC.NVY2017-06-02
00643169410916CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169410916CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
00643169410947CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
00643169448858CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169335592Sprint Quattro®MEDTRONIC, INC.NVY2016-08-07
00643169451476SPRINT QUATTRO®MEDTRONIC, INC.NVY2016-07-31
00643169535930SPRINT QUATTRO SECURE S™ DXAC/DSPMEDTRONIC, INC.NVY2016-07-31
00643169550872CAPSUREFIX® NOVUSMEDTRONIC, INC.NVY2016-07-31
00643169550933Sprint Quattro Secure S®MEDTRONIC, INC.NVY2016-07-31
00643169590496CapSure Sense®MEDTRONIC, INC.NVY2016-04-30
00643169590489CapSure Sense®MEDTRONIC, INC.NVY2016-04-24
00643169590465CapSure Sense®MEDTRONIC, INC.DTB2016-04-22
00643169590472CapSure Sense®MEDTRONIC, INC.NVY2016-04-22
00643169590502CapSure Sense®MEDTRONIC, INC.NVY2016-01-14
00643169590519CapSure Sense®MEDTRONIC, INC.DTB2016-01-14
00643169590526CapSure Sense®MEDTRONIC, INC.NVY2016-01-14
00643169590526CapSure Sense®MEDTRONIC, INC.DTB2016-01-14
00643169590588ATTAIN® BIPOLAR OTWMEDTRONIC, INC.DTB2016-01-14