Sonachill

Basic Information

• Brand Name: Sonachill
• Primary DI: 00868108000274
• Version / Model: 102-17000-0007
• Company Name: FOCUS SURGERY INC
• Labeler DUNS: 101084143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-28
• Public Version: 3
• Public Version Date: 2020-03-02
• Public Version Status: Update
• Public Device Record Key: 226ae912-8e3f-40a8-9ff6-27e2726417f2

Device Description

System used to regulate temperature and oxygen content of sterile water for a procedure.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PLP	High Intensity Ultrasound System For Prostate Tissue Ablation	Gastroenterology, Urology	876.4340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40781	Ultrasonic hyperthermia system	An assembly of devices designed to produce and control the delivery of high heat (i.e., temperatures greater than 43? Celsius) to the body using ultrasonic energy for the intracorporeal or extracorporeal treatment of malignant or benign tumours, or other disease conditions. It is typically computer-controlled and is capable of producing whole-body or localized heating within tissues or organs. Energy delivered to the patient is from either an externally-mounted transducer or a transducer-containing catheter or probe used topically or inserted endoscopically or surgically. Unlike an ultrasound diathermy system, an ultrasound hyperthermia system is not used in physiotherapy applications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00868108000274	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN150011	000
K160942	000