LITHOCLAST

Basic Information

• Brand Name: LITHOCLAST
• Primary DI: 07613353123765
• Version / Model: FR-312
• Catalog Number: M0068403480
• 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: 2018-03-12
• Public Version: 3
• Public Version Date: 2021-01-08
• Public Version Status: Update
• Public Device Record Key: 8fe0de2d-aad1-440d-9d00-83cfceb58aa9

Device Description

Swiss LithoClast Trilogy Disposable Probe kit Ø1.1x520mm

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
60703	Ultrasonic lithotripsy system probe, single-use	A slender, metal, tubular device that is coaxially attached to an ultrasonic lithotripsy system handpiece [a hand-held acoustic transducer that produces ultrasound (US) waves] and intended to transmit US waves to calculi (stones) in the urinary tract (i.e., kidneys, ureters, and bladder) for their fragmentation. Its distal end is brought into contact with calculi and transmits the energy, breaking down the calculi in the body for removal through its lumen. This device is introduced through the working channel of an appropriate endoscope (e.g., a percutaneous nephroscope for ureteral stones). This is a single-use device.	No	Active
60461	Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use	A sterile, slender, rod-like device intended to be used as part of an intracorporeal lithotripsy system to transmit shock waves from electrohydraulic or pneumatic sources directly to a calculus in the urinary tract (i.e., kidneys, ureters, and bladder), providing high-speed fragmentation of the calculus in situ. It is typically made of high-grade stainless steel, may be rigid or semi-flexible, and is available in a variety of sizes and lengths. It may be introduced endoscopically through a natural body orifice or a surgically made opening. This is a single-use device.	No	Obsolete
47464	Intracorporeal lithotripsy suction system	An assembly of devices designed for use with an intracorporeal lithotripsy system to evacuate, by suction, the irrigation fluid-containing fragments of urinary calculi from the kidneys, ureters, and bladder during lithotripsy. It typically consists of a pneumatically-powered pump that creates suction via the venturi mechanism, a vacuum gauge, vacuum control knob, a compressed air connector, tubing, a moisture filter, and possibly a microbial filter. The vacuum created by the pump is applied to the body through the tubing and an inserted probe, for the removal of the calculi in a stone catcher and the fluid in a collection container.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613353123765	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173234	000

Device Sizes

Type	Value	Unit	Text
Length	520	Millimeter
Outer Diameter	1.1	Millimeter