Duns Number:883925562
Device Description: ANTIMICROBIAL FOAM WOUND DRESSING WITH METHYLENE BLUE, GENTIAN VIOLET, AND SILVER
Catalog Number
72040414
Brand Name
DermaBlue + Foam
Version/Model Number
72040414
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 04, 2021
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
c07422b9-dba1-4d5c-94dc-3f042220127f
Public Version Date
October 05, 2021
Public Version Number
2
DI Record Publish Date
April 16, 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 | 137 |
U | Unclassified | 36 |