Sprint Quattro Secure S®

GUDID 00643169309753

LEAD 6935M49 USA DF4 EN NG ACI

MEDTRONIC, INC.

Endocardial defibrillation lead
Primary Device ID00643169309753
NIH Device Record Key21a4e580-125f-4c81-9726-c7f1b783d796
Commercial Distribution Discontinuation2018-06-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSprint Quattro Secure S®
Version Model Number6935M49
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter
Length49 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169309753 [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 Number5
Public Version Date2018-08-13
Device Publish Date2014-09-23

On-Brand Devices [Sprint Quattro Secure S®]

00613994808004LEAD 6935M49 DF4 ACTIVE SC US EN
00613994718891LEAD 6935M97 DF4 ACTIVE SC US EN
00613994718877LEAD 6935M72 DF4 ACTIVE SC US EN
00613994718853LEAD 6935M62 DF4 ACTIVE SC US EN
00613994718839LEAD 6935M55 DF4 ACTIVE SC US EN
00643169550971LEAD 6947M97 SPRINT US DF4 MCRD NG ACI
00643169550964LEAD 6947M72 SPRINT US DF4 MCRD NG ACI
00643169550957LEAD 6947M62 SPRINT US DF4 MCRD NG ACI
00643169550940LEAD 6947M55 SPRINT US DF4 MCRD NG ACI
00643169550933LEAD 6947M49 SPRINT US DF4 MCRD NG ACI
00643169550926LEAD 6935M97 US DF4 NG ACI
00643169550919LEAD 6935M72 US DF4 NG ACI
00643169550902LEAD 6935M62 US DF4 NG ACI
00643169550896LEAD 6935M55 US DF4 NG ACI
00643169550889LEAD 6935M49 US DF4 NG ACI
00643169309791LEAD 6935M97 USA DF4 EN NG ACI
00643169309784LEAD 6935M72 USA DF4 EN NG ACI
00643169309777LEAD 6935M62 USA DF4 EN NG ACI
00643169309760LEAD 6935M55 USA DF4 EN NG ACI
00643169309753LEAD 6935M49 USA DF4 EN NG ACI

Trademark Results [Sprint Quattro Secure S]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPRINT QUATTRO SECURE S
SPRINT QUATTRO SECURE S
77336605 3689990 Live/Registered
Medtronic, Inc.
2007-11-26

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