Visual-ICE MRI Mobile Connection Panel FPRCH7100

GUDID 00859019006332

MRI Mobile Connection Panel

GALIL MEDICAL INC.

General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic 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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