Sprint Quattro Secure S MRI™ SureScan™

GUDID 00763000180126

LEAD 6935M62 MRI US DF4 RCMCRD

MEDTRONIC, INC.

Endocardial defibrillation lead
Primary Device ID00763000180126
NIH Device Record Key69fb758b-93c5-4e28-adbb-8cb0d0b6128f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSprint Quattro Secure S MRI™ SureScan™
Version Model Number6935M62
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

Device Dimensions

Length62 Centimeter
Length62 Centimeter
Length62 Centimeter
Length62 Centimeter
Length62 Centimeter
Length62 Centimeter
Length62 Centimeter
Length62 Centimeter
Length62 Centimeter
Length62 Centimeter
Length62 Centimeter
Length62 Centimeter
Length62 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000180126 [Primary]

FDA Product Code

NVYPermanent defibrillator electrodes

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-12
Device Publish Date2024-11-04

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

00643169690042LEAD 693565 SPRINT QUATTRO US MRI
00643169690035LEAD 693558 SPRINT QUATTRO US MRI
00643169356566LEAD 6935M62 QUATTRO SECURE S MRI US
00643169356559LEAD 6935M55 QUATTRO SECURE S MRI US
00763000180126LEAD 6935M62 MRI US DF4 RCMCRD
00763000180119LEAD 6935M55 MRI US DF4 RCMCRD
00763000180058LEAD 693565 SPRINT MRI US RCMCRD
00763000180041LEAD 693558 SPRINT MRI US RCMCRD

Trademark Results [Sprint Quattro Secure S MRI]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPRINT QUATTRO SECURE S MRI
SPRINT QUATTRO SECURE S MRI
85959274 4874807 Live/Registered
Medtronic, Inc.
2013-06-13

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