Duns Number:047724226
Device Description: Calcium Alginate Wound Dressing (20) - Areza Calcium Alginate is made of natural fibers de Calcium Alginate Wound Dressing (20) - 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 through a process of ion exchange over the wound, maintaining a moist environment for wound healing. They are soft and conformable, easy to pack, tuck or apply over irregular-shaped wounds. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal. Indicated for wounds with moderate to heavy exudate, such as pressure ulcers, infected wounds, and venous insufficiency ulcers. Alginates require a secondary dressing to be secured on the wound.
Catalog Number
CA4420
Brand Name
Areza Medical
Version/Model Number
CA4420
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)
-
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
95198c4d-09aa-4be6-97fe-e86dd8cc8bfe
Public Version Date
October 17, 2022
Public Version Number
1
DI Record Publish Date
October 07, 2022
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 |