Temperature Sensor FAT8000000

GUDID 07290015487061

Temperature Sensor - Use only with IceCure Cryogenic device

ICECURE MEDICAL LTD

Cryosurgical system temperature probe Cryosurgical system temperature probe Cryosurgical system temperature probe Cryosurgical system temperature probe Cryosurgical system temperature probe Cryosurgical system temperature probe Cryosurgical system temperature probe

• Primary Device ID: 07290015487061
• NIH Device Record Key: de06aee0-9470-45c1-a6b3-dcd894607a4f
• Commercial Distribution Discontinuation: 2022-06-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Temperature Sensor
• Version Model Number: FAT8000000
• Catalog Number: FAT8000000
• Company DUNS: 514758619
• Company Name: ICECURE MEDICAL LTD
• Device Count: 1
• DM Exempt: true
• 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: 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: +16468443066
• Email: icecuresupport@icecure-medical.com
• Phone: +16468443066
• Email: icecuresupport@icecure-medical.com
• Phone: +16468443066
• Email: icecuresupport@icecure-medical.com
• Phone: +16468443066
• Email: icecuresupport@icecure-medical.com
• Phone: +16468443066
• Email: icecuresupport@icecure-medical.com
• Phone: +16468443066
• Email: icecuresupport@icecure-medical.com
• Phone: +16468443066
• Email: icecuresupport@icecure-medical.com

Device Dimensions

• Shaft Length: 170 Millimeter
• Needle Gauge: 14 Gauge
• Shaft Length: 170 Millimeter
• Needle Gauge: 14 Gauge
• Shaft Length: 170 Millimeter
• Needle Gauge: 14 Gauge
• Shaft Length: 170 Millimeter
• Needle Gauge: 14 Gauge
• Shaft Length: 170 Millimeter
• Needle Gauge: 14 Gauge
• Shaft Length: 170 Millimeter
• Needle Gauge: 14 Gauge
• Shaft Length: 170 Millimeter
• Needle Gauge: 14 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015487061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183213

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: 2022-06-15
• Device Publish Date: 2022-06-07

Devices Manufactured by ICECURE MEDICAL LTD

• 07290015487061 - Temperature Sensor: 2022-06-15Temperature Sensor - Use only with IceCure Cryogenic device
• 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
• 07290015487047 - Cryoprobe D2.4 mm/13G, 124 mm, Trocar, Spheric.: 2019-11-01 Cryoprobe-Use only with IceCure Cryogenic Device
• 07290015487054 - Cryoprobe D2.4 mm/13G, 134 mm, Trocar, Elliptic.: 2019-11-01 Cryoprobe-Use only with IceCure Cryogenic Device
• 07290015487078 - Cryoprobe D2.4 mm/13G, 180 mm, Trocar, Elliptic.: 2019-11-01 Cryoprobe-Use only with IceCure Cryogenic Device
• 07290015487085 - Cryoprobe D3.4 mm/10G, 185 mm, Trocar, Elliptic.: 2019-11-01 Cryoprobe-Use only with IceCure Cryogenic Device