Visual-ICE MRI Mobile Connection Panel FPRCH7100

GUDID 00859019006332

MRI Mobile Connection Panel

GALIL MEDICAL INC.

General cryosurgical system, cryogen gas, electronic

• Primary Device ID: 00859019006332
• NIH Device Record Key: c37afaae-b30d-42dc-8427-94cfd21b550d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visual-ICE MRI Mobile Connection Panel
• Version Model Number: FPRCH7100
• Catalog Number: FPRCH7100
• Company DUNS: 809529469
• Company Name: GALIL MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature: between -15 and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859019006332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173037

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-17
• Device Publish Date: 2018-03-07

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• 07290104831140 - HEATfx 2.1 20cm Needle: 2020-08-24 Microwave ablation needle
• 07290104831157 - HEATfx 2.1 15cm Needle: 2020-08-24 Microwave ablation needle
• 00859019006417 - ICEfx Cryoablation System: 2020-03-30 Cryoablation System