Sonolith i-move Visio-Track Module TMS 239271

GUDID 03661690000113

SONOLITH® i-move Visio-Track medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency.

EDAP-TMS FRANCE

Electromechanical lithotripsy system, extracorporeal
Primary Device ID03661690000113
NIH Device Record Key9dbf1357-5117-4acf-8b67-cf3eccdd2152
Commercial Distribution Discontinuation2024-05-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSonolith i-move Visio-Track Module
Version Model NumberTMS 239271
Catalog NumberTMS 239271
Company DUNS383113362
Company NameEDAP-TMS FRANCE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(512) 832-7956
Emailmhull@edap-usa.com
Phone(512) 832-7956
Emailmhull@edap-usa.com
Phone(512) 832-7956
Emailmhull@edap-usa.com
Phone(512) 832-7956
Emailmhull@edap-usa.com
Phone(512) 832-7956
Emailmhull@edap-usa.com
Phone(512) 832-7956
Emailmhull@edap-usa.com
Phone(512) 832-7956
Emailmhull@edap-usa.com
Phone(512) 832-7956
Emailmhull@edap-usa.com
Phone(512) 832-7956
Emailmhull@edap-usa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103661690000113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNSLithotriptor, Extracorporeal Shock-Wave,Urological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2024-12-11
Device Publish Date2016-09-21

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