Duns Number:832217439
Device Description: Energy generator and control unit ( t be used in conjuction with the PACE Applicator) for Energy generator and control unit ( t be used in conjuction with the PACE Applicator) for the delivery of Extracorporeal Shock Waves (ESW) for the treatment of Diabetic Foot Ulcers.
Catalog Number
-
Brand Name
dermaPACE Console
Version/Model Number
DEP0330
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
c201d920-1f57-4d79-b486-a533c5cdf2de
Public Version Date
July 08, 2021
Public Version Number
2
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 |