MRI SeedNet®Gold Cryoablation System FPRCH2035

GUDID 07290104830020

MRI Cryoablation System

GALIL MEDICAL LTD

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Primary Device ID	07290104830020
NIH Device Record Key	b8f85cdf-1fd1-4395-9dd3-f708fa76cda1
Commercial Distribution Status	In Commercial Distribution
Brand Name	MRI SeedNet®Gold Cryoablation System
Version Model Number	FPRCH2035
Catalog Number	FPRCH2035
Company DUNS	531854560
Company Name	GALIL MEDICAL LTD
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

Operating and Storage Conditions

Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 85 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290104830020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K021261

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	2018-07-06
Device Publish Date	2016-08-15

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07290104830099 - IceRod® He-Thaw Prostate Cryoablation Kit / Presic	2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template