GUDID 00721902183072

LEAD 6996SQ58 DEFIB SUB US MR

MEDTRONIC, INC.

Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead
Primary Device ID00721902183072
NIH Device Record Keyb573bf02-64a0-458c-ad8a-821e9968e16e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6996SQ58
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 Productfalse
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

Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 Centimeter
Length58 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
GS100721902183072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTBpermanent pacemaker Electrode

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 Date2014-09-23

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