Sonolith Electrode

Basic Information

• Brand Name: Sonolith Electrode
• Primary DI: 03661690000045
• Version / Model: TMS 220830
• Catalog Number: TMS220830
• Company Name: EDAP-TMS FRANCE
• Labeler DUNS: 383113362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-08
• Public Version: 2
• Public Version Date: 2018-09-03
• Public Version Status: Update
• Public Device Record Key: 3347a986-2d0d-4ee3-901f-7e16cdd492e1

Device Description

The SONOLITH® electrode is the consumable/ disposable component for the SONOLITH® lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency.

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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMZ	Table, Cystometric, Electric	Gastroenterology, Urology	876.4890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18415	Electromechanical lithotripsy system, extracorporeal	An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by an electromechanical generator. This generator contains a coil attached to a thin metallic membrane; a magnetic field is produced by an electric current conducted through the coil, and shock waves are generated when the metallic membrane is repelled by the magnetic field. The system also includes a treatment table, an imaging system, and an operator's console. This [extracorporeal shock wave lithotripsy (ESWL)] system is used to disintegrate stones located in the kidneys, urinary tract, gallbladder, or bile/pancreatic ducts.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03661690000045	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K111808	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 35.6 – 86 Degrees Fahrenheit