Duns Number:342585299
Device Description: The DermaGold100® is intended for treatment of - diabetic footulcers- superficial partial The DermaGold100® is intended for treatment of - diabetic footulcers- superficial partial thickness second degree burns in adults (22 years and older). The dermagold100 is indicated for use in conjunction with standard of care burn treatment(s)
Catalog Number
1000014
Brand Name
DermaGold100®
Version/Model Number
OW100-US
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191961,K200926,K191961,K200926
Product Code
PZL
Product Code Name
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Public Device Record Key
c7484569-df33-43d7-9b5d-3bcc011dd2a4
Public Version Date
July 08, 2021
Public Version Number
5
DI Record Publish Date
March 31, 2020
Package DI Number
04260484571656
Quantity per Package
1
Contains DI Package
04260484571649
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |