Duns Number:002329923
Device Description: Extracorporeal Shockwave Lithotripsy (ESWL) System for non-invasive disintegration of cal Extracorporeal Shockwave Lithotripsy (ESWL) System for non-invasive disintegration of calculi located in the kidneys and urinary tract. Comprised of ESWL control unit, Litho arm for Philips BV Pulsera c-arm, Philips BV Pulsera x-ray, Sonoace X6 Ultrasound, Oakworks CFLU401 Table.
Catalog Number
-
Brand Name
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE
Version/Model Number
P3000002
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 2018
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
LNS
Product Code Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
Public Device Record Key
eee1bb54-a157-4fb7-b9c2-72e71c33c0b7
Public Version Date
October 26, 2018
Public Version Number
4
DI Record Publish Date
February 26, 2018
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. | 47 |