Cardioblate® CryoFlex®

GUDID 00643169183865

PROBE 60SF3 CRYOFLEX 10CM 26L

MEDTRONIC, INC.

General cryosurgical system, cryogen gas, mechanical
Primary Device ID00643169183865
NIH Device Record Key4b5279b8-6423-4602-90b7-2b91fbd83929
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 Batchfalse
Serial Numbertrue
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

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

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169183865 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-19

On-Brand Devices [Cardioblate® CryoFlex®]

00643169305106CLAMP 60CM1 CRYOFLEX PROBE 26L
00643169183889PROBE 60SF2 CRYOFLEX 10CM 26L
00643169183865PROBE 60SF3 CRYOFLEX 10CM 26L
00643169183841PROBE 60SF7 CRYOFLEX 10CM 26L
00643169183834CONSOLE 65CS1 CRYOFLEX 26L
00643169183759REGULATOR 67RAXNA CRYOFLEX NA
00763000114640CLAMP 60CM1 CRYOFLEX PROBE 26L
00763000114633PROBE 60SF7 CRYOFLEX 7CM 26L
00763000114626PROBE 60SF3 CRYOFLEX 10-S 26L
00763000114619PROBE 60SF2 CRYOFLEX 10CM 26L
00763000014995REGULATOR 67RAXE-006 CRYOFLEX NON-ROHS
00763000014988CONSOLE 65CS1-006 CRYOFLEX NON-ROHS

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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