Duns Number:080660602
Device Description: CLASSIC Antibacterial Foam Dressing
Catalog Number
-
Brand Name
Hydrofera Blue
Version/Model Number
HB4514
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
Yes
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
K013462,K013462
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
030c0876-1955-46af-980e-5620d04a277f
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
January 02, 2019
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 |
---|---|---|
U | Unclassified | 1 |