IceSphere™ 1.5 CX Cryoablation Needle FPRPR3573

GUDID 07290104831133

1.5 mm Cryoablation Needle

GALIL MEDICAL LTD

Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set
Primary Device ID07290104831133
NIH Device Record Key750ac15c-ae38-4b1c-9afa-6507a4b8943b
Commercial Distribution StatusIn Commercial Distribution
Brand NameIceSphere™ 1.5 CX Cryoablation Needle
Version Model NumberFPRPR3573
Catalog NumberFPRPR3573
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
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

Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter
Outer Diameter1.5 Millimeter
Shaft Length175 Millimeter

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
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
GS107290104831133 [Primary]

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-23
Device Publish Date2018-09-22

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07290104831133 - IceSphere™ 1.5 CX Cryoablation Needle2018-10-231.5 mm Cryoablation Needle
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 [IceSphere]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ICESPHERE
ICESPHERE
77431013 3562388 Live/Registered
Galil Medical Ltd.
2008-03-25

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