Three IceFORCE ® 2.1 CX Prostate Cryoablation Kit FPRPR3607

GUDID 07290104831058

Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template

GALIL MEDICAL LTD

Cryosurgical set
Primary Device ID07290104831058
NIH Device Record Keyced34ba2-aca9-4d32-a628-16933106fc2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameThree IceFORCE ® 2.1 CX Prostate Cryoablation Kit
Version Model NumberFPRPR3607
Catalog NumberFPRPR3607
Company DUNS531854560
Company NameGALIL MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool, Dry, Place

Device Identifiers

Device Issuing AgencyDevice ID
GS107290104831058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.