Duns Number:481967776
Device Description: The device is indicated for extracorporeal shock wave treatment.
Catalog Number
21362.0102
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
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
K202112,P080028
Product Code
NBN
Product Code Name
Generator, Shock-Wave, For Pain Relief
Public Device Record Key
dfe04ebd-fc0b-4e5d-8104-c029e1512534
Public Version Date
July 08, 2021
Public Version Number
2
DI Record Publish Date
April 08, 2021
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 |