Duns Number:481967776
Device Description: The device is indicated for extracorporeal shock wave treatment.
Catalog Number
-
Brand Name
DUOLITH®
Version/Model Number
SD1 T-Top
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2021
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
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
5aea63d8-e266-4ad5-978f-5eda9bbf16a8
Public Version Date
April 30, 2021
Public Version Number
3
DI Record Publish Date
March 23, 2020
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 |