Duns Number:047724226
Device Description: Areza Calcium Alginate Wound Dressing 4.25" x 4.25" (10) Areza Calcium Alginate is made of Areza Calcium Alginate Wound Dressing 4.25" x 4.25" (10) Areza Calcium Alginate is made of natural 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 for wound healing. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal.
Catalog Number
57354
Brand Name
Areza Medical
Version/Model Number
57354
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
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
14ec49b7-4e76-48df-bd31-4d9cd46ed29b
Public Version Date
November 03, 2020
Public Version Number
1
DI Record Publish Date
October 26, 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 |