XSense Cryoablation System

GUDID 07290015487511

ICECURE MEDICAL LTD

General cryosurgical system, cryogen gas, electronic

• Primary Device ID: 07290015487511
• NIH Device Record Key: 1aa42e3c-971f-4c01-9d00-c7f95841a654
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XSense Cryoablation System
• Version Model Number: CSS-2004054
• Company DUNS: 514758619
• Company Name: ICECURE MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com
• Phone: 18889025716
• Email: icecuresupport@icecure-medical.com

Device Dimensions

• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter
• Weight: 83 Kilogram
• Height: 162 Centimeter
• Depth: 56 Centimeter
• Width: 46 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015487511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240892

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-13
• Device Publish Date: 2025-05-05

Devices Manufactured by ICECURE MEDICAL LTD

• 07290015487535 - Cryoprobe: 2025-05-14 straight handle
• 17290015487549 - Cryoprobe: 2025-05-14 90-degree handle
• 07290015487511 - XSense Cryoablation System: 2025-05-13
• 07290015487511 - XSense Cryoablation System: 2025-05-13
• 07290015487528 - External 25L Dewar: 2025-05-13
• 07290015487061 - Temperature Sensor: 2022-06-15 Temperature Sensor - Use only with IceCure Cryogenic device
• 07290015487290 - PROSENSE™ SYSTEM 100-127 VAC: 2021-08-19 PROSENSE™ SYSTEM 100-127 VAC Straight cryohandle
• 07290015487023 - Cryoprobe D3.4 mm/10G, 127 mm, Trocar, Spheric.: 2019-11-01 Cryoprobe - Use only with IceCure Cryogenic device.
• 07290015487030 - Cryoprobe D3.4 mm/10G, 140 mm, Trocar, Elliptic.: 2019-11-01 Cryoprobe-Use only with IceCure Cryogenic Device