LITHOCLAST

Basic Information

• Brand Name: LITHOCLAST
• Primary DI: 07613353311568
• Version / Model: EN-080B
• Catalog Number: M0068402190
• Company Name: E.M.S. Electro Medical Systems S.A.
• Labeler DUNS: 481233849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-20
• Public Version: 3
• Public Version Date: 2024-05-15
• Public Version Status: Update
• Public Device Record Key: 9cdaa944-77c7-4c5b-9559-83a1e0d8090e

Device Description

Swiss LithoClast Trilogy Max Handpiece

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	876.4480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65258	Electromechanical/ultrasonic lithotripsy system	An assembly of electrically-powered devices designed to generate both: 1) electromechanically-created ballistic shock waves; and 2) ultrasonic waves (used in combination or individually) for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a power regulator/control unit and handpiece. A probe is attached to the handpiece connected to the control unit that supplies the energy for both the electromechanical and ultrasonic functions. The fragmented calculi are removed by suction typically produced by an incorporated suction pump.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613353311568	GS1
Direct Marking	07613353221836	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173234	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 5 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius