Duns Number:047724226
Device Description: Areza Island Wound Dressing 6in x 6in (60) - The fabric adhesive backing layer (6in X 6in) Areza Island Wound Dressing 6in x 6in (60) - The fabric adhesive backing layer (6in X 6in) with a central absorbent non-woven pad (4in X 4in) will make this easily conformable dressing to protect the wounds and reduce the risk of physical and bacterial contamination. Easy to remove unless the wound is dried.
Catalog Number
BG6660
Brand Name
Areza Medical
Version/Model Number
BG6660
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
a9f72caf-602b-4dc5-88b5-fdc7f38b34d9
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 |