Sprint Quattro™ MRI SureScan™

GUDID 00643169858305

LEAD 6946M55 MRI USA SPRINT DF4

MEDTRONIC, INC.

Endocardial defibrillation lead
Primary Device ID00643169858305
NIH Device Record Keyd0617e47-16b0-4f81-bd4e-99392330f08c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSprint Quattro™ MRI SureScan™
Version Model Number6946M55
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter
Length55 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169858305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVYPermanent defibrillator electrodes

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-13
Device Publish Date2017-06-11

On-Brand Devices [Sprint Quattro™ MRI SureScan™]

00643169858329LEAD 6946M62 MRI USA SPRINT DF4
00643169858305LEAD 6946M55 MRI USA SPRINT DF4

Trademark Results [Sprint Quattro]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPRINT QUATTRO
SPRINT QUATTRO
75758564 2635937 Live/Registered
Medtronic, Inc.
1999-07-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.