IceFORCE® 2.1 CX Cryoablation Needle FPRPR3604

GUDID 07290104831027

2.1mm Cryoablation Needle

GALIL MEDICAL LTD

Cryosurgical set
Primary Device ID07290104831027
NIH Device Record Key1f8bb21c-8a99-4692-b014-56341bcb44a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameIceFORCE® 2.1 CX Cryoablation Needle
Version Model NumberFPRPR3604
Catalog NumberFPRPR3604
Company DUNS531854560
Company NameGALIL MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
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

Device Dimensions

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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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290104831027 [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

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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

Trademark Results [IceFORCE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ICEFORCE
ICEFORCE
86541150 4974310 Live/Registered
Galil Medical Ltd.
2015-02-20

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