Duns Number:383113362
Device Description: One piece carbon fiber table for use with SONOLITH® i-move or i-sys lithotripsy devices fo One piece carbon fiber table for use with SONOLITH® i-move or i-sys lithotripsy devices for ESWL(Extracorporeal Shock Wave Lithotnpsy).
Catalog Number
TMS230811
Brand Name
Sonolith Carbon Fiber Table
Version/Model Number
TMS 230811
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
-
Product Code
MMZ
Product Code Name
Table, Cystometric, Electric
Public Device Record Key
90bcccfe-f347-4ed5-90cb-8837ac59c96e
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 |