Lithospec

Basic Information

• Brand Name: Lithospec
• Primary DI: 07290016498455
• Version / Model: LS-6-A999b
• Company Name: MEDISPEC LTD.
• Labeler DUNS: 600300909
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-08
• Public Version: 1
• Public Version Date: 2023-06-16
• Public Version Status: New
• Public Device Record Key: e5870789-3803-4211-850d-44cf7593e47b

Device Description

Intracorporeal Lithoripter

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: Yes
• 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
34231	Electromechanical lithotripsy system, intracorporeal	An assembly of devices designed to create shock waves through electromechanical action for the intracorporeal fragmentation of calculi (stones) in the urinary tract (i.e., kidney, ureter and bladder); the resulting debris may be actively removed or passed out by natural means at a later date. The energy is generated by an integral drive unit which converts electrical energy into mechanical force. The force is applied to an impact hammer that strikes the proximal end of a lithotripsy system probe which is brought into physical contact with the stone to be fragmented, therefore providing high-speed fragmentation of the calculus in situ.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016498455	GS1