GUDID 10885074212804

LEAD 6416-140 5BX TEMP FIX LEAD 10L

MEDTRONIC, INC.

Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead
Primary Device ID10885074212804
NIH Device Record Keya77a92d1-90fc-4ff0-87ad-20f9320a47de
Commercial Distribution Discontinuation2018-04-23
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number6416-140
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count5
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 Batchtrue
Serial Numberfalse
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100885074212807 [Unit of Use]
GS110885074212804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDFELECTRODE, PACEMAKER, TEMPORARY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-02-05
Device Publish Date2015-06-11

Devices Manufactured by MEDTRONIC, INC.

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