IceRod® He-Thaw Prostate Cryoablation Kit / Presic FPRPR4570

GUDID 07290104830099

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

GALIL MEDICAL LTD

Cryosurgical set

• Primary Device ID: 07290104830099
• NIH Device Record Key: 13b808a6-5a74-4003-b325-7279f643fc38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IceRod® He-Thaw Prostate Cryoablation Kit / Presic
• Version Model Number: FPRPR4570
• Catalog Number: FPRPR4570
• 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
• 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

• Device Size Text, specify: 0
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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
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• 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	07290104830099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060390

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

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• 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: 2018-07-06Prostate 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