Duns Number:047724226
Device Description: Areza Foam Dressing with Adhesive Border 6.5” x 6.5” is composed of three layers: 1- a cen Areza Foam Dressing with Adhesive Border 6.5” x 6.5” is composed of three layers: 1- a central polyurethane (PU) foam pad with a size of 4.1” x 4.1” and 5 mm thickness. Foam pad to lay on exuding wounds and is non-adhesive as long as it is used on actively exuding wounds. 2- a very thin PU backing layer which is soft, white in color, breathable, and reinforced with Spunlace, nonwoven fabric mesh. Note: this layer provides water resistance, but it is not waterproof. Meaning liquid may cross from the outer surface to the inside with some delay (normally about 10-20 mins or longer). Unless the foam is soaked, exudate does not cross from the inner surface to outer surface. This dressing is not suitable for showering or swimming. 3- an adhesive layer composed of medical grade Henkel glue that is adhered onto the second layer, the Spunlace, nonwoven fabric mesh.
Catalog Number
FADWR6.5
Brand Name
Areza Medical
Version/Model Number
FADWR6.5
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
de071d35-f1c2-43ab-8206-6ebf6290fdec
Public Version Date
September 30, 2022
Public Version Number
2
DI Record Publish Date
October 27, 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 |