GUDID 00613994776006

BOX 2037A AUTO CONNECTION BOX

MEDTRONIC, INC.

Cardiac cryosurgical system
Primary Device ID00613994776006
NIH Device Record Key814cb693-dbe8-4f21-9704-4f31d82e37e5
Commercial Distribution StatusIn Commercial Distribution
Version Model Number2037A
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994776006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPBCardiac ablation percutaneous catheter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-23

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