GUDID 20613994412984

LEAD 6416-200 5BX TEMP FIX LEAD 10L

MEDTRONIC, INC.

Endocardial pacing lead
Primary Device ID20613994412984
NIH Device Record Key07e4dc3b-1035-44c2-ba4d-b26a33096034
Commercial Distribution Discontinuation2016-10-09
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number6416-200
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
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
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
GS100613994412980 [Unit of Use]
GS120613994412984 [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 Number2
Public Version Date2018-03-29
Device Publish Date2015-06-11

Devices Manufactured by MEDTRONIC, INC.

00763000613617 - Mosaic™7308C2025-03-11 SIZERS 7308C MOSAIC CINCH AORTIC MDR
00763000613624 - Mosaic Ultra™7308U2025-03-11 SIZERS 7308U MOSAIC ULTRA AORTIC MDR
00763000613631 - Mosaic™73102025-03-11 OBTURATORS 7310 MOSAIC MITRAL MDR
00763000613648 - NA2025-03-11 HANDLE 7639 VALVE MDR
00763000613655 - NA2025-03-11 HANDLE 7639XL VALVE XL MDR
00763000613662 - NA2025-03-11 ACCESSORY 7642 LOCK NUT MDR
00763000614034 - Hancock™ II 75052025-03-11 OBTURATOR 7505SET HK II AORTIC MDR
00763000614041 - Hancock™ II 75102025-03-11 OBTURATOR 7510SET HK II MITRAL MDR

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