Duns Number:315304071
Device Description: LITHOTRIPTER 3000 for stone fragmentation of renal hollow system (renal pelvis and calyce LITHOTRIPTER 3000 for stone fragmentation of renal hollow system (renal pelvis and calyces) and in the upper, middle and lower ureter, for extracorporal shock wave lithotripsy, with articulated arm, total energy (12mm) 123mJ, peak pressure (p+) 8 - 126MPa, penetration max. 165mm, focal length F1/F2/F3 (X/YxZ): F1 3,7x30/F2 4,8x32/F3 8,7x63mm, U: 110-120VAC, 50/60Hz, Dim wxhxd 1000x700x1200mm
Catalog Number
3000.012
Brand Name
PIEZOLITH
Version/Model Number
3000012
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
LNS
Product Code Name
Lithotriptor, extracorporeal shock-wave,urological
Public Device Record Key
3acb92b1-4430-4bf1-ace5-64fb2e0291a1
Public Version Date
April 21, 2021
Public Version Number
3
DI Record Publish Date
July 21, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |