MRI SeedNet®Gold Console FPRCH2033

GUDID 07290104830914

MRI Cryoablation Console

GALIL MEDICAL LTD

General cryosurgical system, cryogen gas, electronic
Primary Device ID07290104830914
NIH Device Record Keybac86dc8-88a9-4895-bedd-7ed347d195c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMRI SeedNet®Gold Console
Version Model NumberFPRCH2033
Catalog NumberFPRCH2033
Company DUNS531854560
Company NameGALIL MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 85 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290104830914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-15

Devices Manufactured by GALIL MEDICAL LTD

07290104831195 - MultiPoint 1.5 Thermal Sensor2020-11-09 1.5mm Multi-Point Thermal Sensor (MTS)
07290104831164 - MultiPoint 1.5 Thermal Sensor2020-08-24 1.5mm Multi-Point Thermal Sensor (MTS)
07290104831133 - IceSphere™ 1.5 CX Cryoablation Needle2018-10-23 1.5 mm Cryoablation Needle
07290104830020 - MRI SeedNet®Gold Cryoablation System2018-07-06 MRI Cryoablation System
07290104830068 - IceSeed® Prostate Cryoablation Kit / SeedNet® Syst2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensors, Urethral Warming Set, Prostate Template
07290104830075 - IceSeed® Prostate Cryoablation Kit / Presice® Syst2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template
07290104830082 - IceRod® Prostate Cryoablation Kit / SeedNet® Syste2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template
07290104830099 - IceRod® He-Thaw Prostate Cryoablation Kit / Presic2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template

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