Temperature Sensor FAT8000000

GUDID 07290015487061

Temperature Sensor - Use only with IceCure Cryogenic device

ICECURE MEDICAL LTD

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