Sprint Quattro Secure S MRI™ SureScan™

Primary DI
00643169356559
Brand
Sprint Quattro Secure S MRI™ SureScan™
Company
MEDTRONIC, INC.
Model
6935M55
Device description
LEAD 6935M55 QUATTRO SECURE S MRI US
Published
2015-09-21
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P920015151

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P920015151MEDTRONIC(R) TRANSVENE LEAD SYSTEMMedtronic, Inc.1993-12-09NVY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169356559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169356559006431693565596431693565590643169356559

GMDN Terms#

Term, Definition table
TermDefinition
Endocardial defibrillation leadA sterile, 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
Storage Environment Temperature0 Degrees Fahrenheit104 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#

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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.DTB2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
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
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.DTB2016-01-14
00643169590526CapSure Sense®MEDTRONIC, INC.NVY2016-01-14
00643169590588ATTAIN® BIPOLAR OTWMEDTRONIC, INC.DTB2016-01-14
00643169590632ATTAIN STARFIX™MEDTRONIC, INC.DTB2016-01-14
00643169590649ATTAIN STARFIX™MEDTRONIC, INC.DTB2016-01-14
00643169590656ATTAIN STARFIX™MEDTRONIC, INC.DTB2016-01-14