Cryoprobe

GUDID 07290015487535

straight handle

ICECURE MEDICAL LTD

Hand-held cryosurgical system handpiece tip

• Primary Device ID: 07290015487535
• NIH Device Record Key: 34fe3276-d224-4f6d-bd3d-223fff530450
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cryoprobe
• Version Model Number: CP-2004058
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

Device Dimensions

• Needle Gauge: 10 Gauge
• Stent Length: 140 Millimeter
• Needle Gauge: 10 Gauge
• Stent Length: 140 Millimeter
• Needle Gauge: 10 Gauge
• Stent Length: 140 Millimeter
• Needle Gauge: 10 Gauge
• Stent Length: 140 Millimeter
• Needle Gauge: 10 Gauge
• Stent Length: 140 Millimeter
• Needle Gauge: 10 Gauge
• Stent Length: 140 Millimeter
• Needle Gauge: 10 Gauge
• Stent Length: 140 Millimeter
• Needle Gauge: 10 Gauge
• Stent Length: 140 Millimeter
• Needle Gauge: 10 Gauge
• Stent Length: 140 Millimeter
• Needle Gauge: 10 Gauge
• Stent Length: 140 Millimeter
• Needle Gauge: 10 Gauge
• Stent Length: 140 Millimeter
• Needle Gauge: 10 Gauge
• Stent Length: 140 Millimeter
• Needle Gauge: 10 Gauge
• Stent Length: 140 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1000 millibar
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015487535 [Primary]
GS1	17290015487532 [Package]; Package: Box [5 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-14
• Device Publish Date: 2025-05-06

On-Brand Devices [Cryoprobe]

• 17290015487549: 90-degree handle
• 07290015487535: straight handle