FDA.reportPublic FDA data

Sprint Quattro Secure MRI™ SureScan™

Primary DI
00763000180317
Brand
Sprint Quattro Secure MRI™ SureScan™
Company
MEDTRONIC, INC.
Model
6947M55
Device description
LEAD 6947M55 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
00763000180317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000180317007630001803177630001803170763000180317

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
Length55Centimeter

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
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
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.NVY2023-11-02
00802526496868RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526496967RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526496981RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526497001RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592805RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592829RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592850RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592867RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
04035479157821EFH-6F-WBIOTRONIK SE & Co. KGDTB2017-11-22
04035479157838EFH-6F-WBIOTRONIK SE & Co. KGDTB2017-11-17
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169453180CapSureFix™ NovusMEDTRONIC, INC.NVY2017-06-02
00643169410916CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
00643169410916CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169410947CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
00643169448858CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
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
00643169356559Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2015-09-21
00643169356566Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2015-09-21