Duns Number:047724226
Device Description: Areza Antibacterial Alginate with Silver is made of natural alginate fibers derived from s Areza Antibacterial Alginate with Silver is made of natural alginate fibers derived from seaweed through a series of special processes. Designed to be highly absorbent, the dressing rapidly absorbs exudates and forms a gel-like covering over the wound, maintaining a moist environment ideal for wound healing. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal.Areza Antibacterial Alginate with Silver can restrain the bacteria growing and reduce further bacterial infection. It has been tested in vitro and found to be effective against bacteria such as: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Escherichia coli, Pseudomonsa aeruginosa, Klebsiella pneumoniae.
Catalog Number
57359
Brand Name
Areza Medical
Version/Model Number
57359
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
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
02cc4257-f61f-4089-80ba-03e07b38e644
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
October 05, 2020
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 | 15 |
| U | Unclassified | 5 |