Cardioblate® CryoFlex®

GUDID 00763000114626

PROBE 60SF3 CRYOFLEX 10-S 26L

MEDTRONIC, INC.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 00763000114626
• NIH Device Record Key: 272f6cac-de1b-4470-8bf1-487f5e7af802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardioblate® CryoFlex®
• Version Model Number: 60SF3
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000114626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123733

FDA Product Code

• OCL: Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-14
• Device Publish Date: 2018-05-07

On-Brand Devices [Cardioblate® CryoFlex®]

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