Duns Number:383113362
Device Description: SONOLITH® i-move Visio-Track medical device is a lithotripter of ESWL type (Extracorporeal 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.
Catalog Number
TMS 239271
Brand Name
Sonolith i-move Visio-Track Module
Version/Model Number
TMS 239271
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111808
Product Code
LNS
Product Code Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
Public Device Record Key
9dbf1357-5117-4acf-8b67-cf3eccdd2152
Public Version Date
September 17, 2018
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |