GUDID 00613994759467

CABLE 68005 EGM 26L

MEDTRONIC, INC.

Cardiac radio-frequency ablation system generator
Primary Device ID00613994759467
NIH Device Record Key48fe3d52-d5d8-4632-89b7-fc16f60822b6
Commercial Distribution StatusIn Commercial Distribution
Version Model Number68005
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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

Device Dimensions

Length457 Centimeter
Length457 Centimeter
Length457 Centimeter
Length457 Centimeter
Length457 Centimeter
Length457 Centimeter
Length457 Centimeter
Length457 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994759467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCLSurgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-27
Device Publish Date2016-05-02

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