Duns Number:047724226
Device Description: Ultra-Absorbent Silicone Foam with Adhesive Border 4" x 4" (pad: 2.5" x 2.5") - consist of Ultra-Absorbent Silicone Foam with Adhesive Border 4" x 4" (pad: 2.5" x 2.5") - consist of a fenestrated silicone wound contact layer, a triple-layer ultra-absorbent pad, and a vapor permeable, waterproof polyurethane (PU) film backing.
Catalog Number
45334
Brand Name
Areza Medical
Version/Model Number
45334
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
bff40e0f-5f9e-46e2-832c-bf88ce349af0
Public Version Date
November 04, 2020
Public Version Number
1
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 |