Duns Number:047724226
Device Description: Areza Island Wound Dressing (Bordered Gauze) is a non-adherent, minimally absorptive, and Areza Island Wound Dressing (Bordered Gauze) is a non-adherent, minimally absorptive, and self adhesive dressing. The central pad (4"x4") is composed of non-woven viscose fibers which on wound facing surace covered with a fenestrated non-adherent layer. The backing of the dressing (6"x6") is made of polyurethane and Spunlace fabric and is covdered wih adhesives. The non-adherent wound facing layer provides this dressing the unique ability to be used on minimally exuding wounds. This conformable dressing may reduce risk of physical damage and bacterial contamination of wounds. The dressings are individually packed and are sterile.
Catalog Number
57255
Brand Name
Areza Medical
Version/Model Number
57255
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
893aac10-821e-44a4-8416-0496b14eae6e
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 |