Duns Number:832217439
Device Description: Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPACE, for the Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPACE, for the treatment of diabetic foot uclers
Catalog Number
-
Brand Name
dermaPACE Applicator
Version/Model Number
DAP0332
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
DEN160037
Product Code
PZL
Product Code Name
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Public Device Record Key
5e388be3-4a58-4053-a21c-cda42c1c704e
Public Version Date
February 02, 2021
Public Version Number
1
DI Record Publish Date
January 25, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |