GUDID 00763000011147

CONSOLE 106A3 GEN V ROHS PLX

MEDTRONIC, INC.

Cardiac cryosurgical system
Primary Device ID00763000011147
NIH Device Record Key56854249-c9b0-4c55-9d5f-4050b8f9d492
Commercial Distribution StatusIn Commercial Distribution
Version Model Number106A3
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 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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile: handle with care

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000011147 [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 Date2018-01-18

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