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 ID: 07290104831058
• NIH Device Record Key: ced34ba2-aca9-4d32-a628-16933106fc2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Three IceFORCE ® 2.1 CX Prostate Cryoablation Kit
• Version Model Number: FPRPR3607
• Catalog Number: FPRPR3607
• Company DUNS: 531854560
• Company Name: GALIL MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool, Dry, Place

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290104831058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152133

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

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

Devices Manufactured by GALIL MEDICAL LTD

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• 07290104831164 - MultiPoint 1.5 Thermal Sensor: 2020-08-24 1.5mm Multi-Point Thermal Sensor (MTS)
• 07290104831133 - IceSphere™ 1.5 CX Cryoablation Needle: 2018-10-23 1.5 mm Cryoablation Needle
• 07290104830020 - MRI SeedNet®Gold Cryoablation System: 2018-07-06 MRI Cryoablation System
• 07290104830068 - IceSeed® Prostate Cryoablation Kit / SeedNet® Syst: 2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensors, Urethral Warming Set, Prostate Template
• 07290104830075 - IceSeed® Prostate Cryoablation Kit / Presice® Syst: 2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template
• 07290104830082 - IceRod® Prostate Cryoablation Kit / SeedNet® Syste: 2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template
• 07290104830099 - IceRod® He-Thaw Prostate Cryoablation Kit / Presic: 2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template