IceSphere® 1.5 90° Cryoablation Needle FPRPR3560

GUDID 07290104830945

1.5mm 90 degree Cryoablation Needle

GALIL MEDICAL LTD

Cryosurgical set

• Primary Device ID: 07290104830945
• NIH Device Record Key: 16623dd0-23bb-4e82-b0f5-b2915ea977fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IceSphere® 1.5 90° Cryoablation Needle
• Version Model Number: FPRPR3560
• Catalog Number: FPRPR3560
• 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: false
• 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

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
• 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	07290104830945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141485

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

On-Brand Devices [IceSphere® 1.5 90° Cryoablation Needle]

• 07290104830945: 1.5mm 90 degree Cryoablation Needle
• 07290104830259: 1.5mm 90 degree Cryoablation Needle