Duns Number:481967776
Device Description: Equipment for the extracorporeal induced shock and pressure wave therapy for stationary an Equipment for the extracorporeal induced shock and pressure wave therapy for stationary and mobile use.
Catalog Number
-
Brand Name
DUOLITH®
Version/Model Number
SD1 T-Top
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
P080028
Product Code
NBN
Product Code Name
Generator, Shock-Wave, For Pain Relief
Public Device Record Key
0ff3d470-083a-4d3a-9162-898eac6f966c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 27, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |
| 3 | A medical device with high risk that requires premarket approval | 7 |