Visual-ICE MRI Junction Box Assembly FPRCH7050

GUDID 00859019006325

MRI Junction Box Assembly

GALIL MEDICAL INC.

General cryosurgical system, cryogen gas, electronic

• Primary Device ID: 00859019006325
• NIH Device Record Key: 1985c9d9-725f-4f4a-9fb6-1bd4b184f616
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visual-ICE MRI Junction Box Assembly
• Version Model Number: FPRCH7050
• Catalog Number: FPRCH7050
• 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	00859019006325 [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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