Swiss LithoClast Select

Basic Information

• Brand Name: Swiss LithoClast Select
• Primary DI: 07613353116095
• Version / Model: FT-148UR
• Catalog Number: M006840701UR0
• 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: 2017-02-13
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: df200699-6dcd-4d1e-a921-fceb562d9044

Device Description

Swiss LithoClast™ Ultra Console Upgraded Refurbished

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
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	876.4480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47099	Pneumatic/ultrasonic lithotripsy system control unit	A mains electricity (AC-powered) component of a pneumatic/ultrasonic intracorporeal lithotripsy system designed to regulate the energy delivered to fragment the stones (i.e., renal, ureteral, urethral, and bladder calculi) for their removal. It is typically connected to a supply of hospital grade compressed air (pipeline/compressor) and has a twin function: 1) to provide and regulate the pneumatic pressure pulses which propagate to the distal tip of the mechanical probe via its handpiece; and 2) to deliver and control electrical energy to the ultrasonic handpiece and its probe. It may also facilitate the removal of the calculi via a suction system and fragmented stone catcher.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613353116095	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K012445	000