ICEfx Cryoablation System Cart FPRCH8010

GUDID 00859019006387

Cryoablation System Accessory

GALIL MEDICAL INC.

General cryosurgical system, cryogen gas, electronic

• Primary Device ID: 00859019006387
• NIH Device Record Key: fcdca268-7610-4a7e-87f3-33d985e8e562
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICEfx Cryoablation System Cart
• Version Model Number: FPRCH8010
• Catalog Number: FPRCH8010
• Company DUNS: 809529469
• Company Name: GALIL MEDICAL INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00859019006387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181153

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-17
• Device Publish Date: 2018-08-01

Devices Manufactured by GALIL MEDICAL INC.

• 07290104831171 - HEATfx 2.1 20cm Needle: 2020-11-09 Microwave ablation needle
• 07290104831188 - HEATfx 2.1 15cm Needle: 2020-11-09 Microwave ablation needle
• 00859019006936 - HEATfx Microwave Ablation System: 2020-10-02 Microwave ablation system console
• 00859019006394 - HEATfx Microwave Ablation System: 2020-08-24 Microwave ablation system console
• 00859019006400 - HEATfx Cart: 2020-08-24 Microwave Ablation System Accessory
• 07290104831140 - HEATfx 2.1 20cm Needle: 2020-08-24 Microwave ablation needle
• 07290104831157 - HEATfx 2.1 15cm Needle: 2020-08-24 Microwave ablation needle
• 00859019006417 - ICEfx Cryoablation System: 2020-03-30 Cryoablation System