Econolith E3000

Basic Information

• Brand Name: Econolith E3000
• Primary DI: 07290016498301
• Version / Model: SW-6-A999b
• Company Name: MEDISPEC LTD.
• Labeler DUNS: 600300909
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-08
• Public Version: 1
• Public Version Date: 2018-09-10
• Public Version Status: New
• Public Device Record Key: c33be345-8799-4f81-934b-89f005a14e85

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
LNS	Lithotriptor, Extracorporeal Shock-Wave,Urological	Gastroenterology, Urology	876.5990	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35711	Electrohydraulic lithotripsy system	An assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. It typically comprises a generator-powered probe which fires energy pulses at the stone's centre while the probe is irrigated with a saline solution. The collapse of the resulting plasma bubble causes a hydraulic shock that fragments the stone into several pieces which can then be removed using surgical instruments (e.g., a grasping instrument or stone basket).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016498301	GS1

Premarket Submissions

Submission Number	Supplement Number
K040461	000