Cardioblate™ CryoFlex™

GUDID 00643169983045

PROBE 60SF3-010 CRYOFLEX 10-S US

MEDTRONIC, INC.

General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical
Primary Device ID00643169983045
NIH Device Record Key3ac927c1-c51d-42b1-b77a-37ecbc54acf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioblate™ CryoFlex™
Version Model Number60SF3
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 Usetrue
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
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

Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the probe at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169983045 [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 Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-25
Device Publish Date2019-11-17

On-Brand Devices [Cardioblate™ CryoFlex™]

00643169983069CLAMP 60CM1-010 CRYOFLEX PROBE US
00643169983045PROBE 60SF3-010 CRYOFLEX 10-S US
00643169983038PROBE 60SF2-010 CRYOFLEX 10CM US
00643169983052PROBE 60SF7-010 CRYOFLEX 7CM US

Trademark Results [Cardioblate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARDIOBLATE
CARDIOBLATE
78264538 2875737 Live/Registered
Medtronic, Inc.
2003-06-19
CARDIOBLATE
CARDIOBLATE
76017616 2672681 Dead/Cancelled
Medtronic, Inc.
2000-03-29

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