Duns Number:047724226
Device Description: Ultra-Absorbent Silicone Foam with Adhesive Border 6" x 6" (pad: 4.15" x 4.15") is a super Ultra-Absorbent Silicone Foam with Adhesive Border 6" x 6" (pad: 4.15" x 4.15") is a superior absorbent dressing for moderate to high wound exudates management. This sterile dressing helps maintain a moist wound healing environment with no irritation upon removal, minimizes trauma to the wound, and reduces pain during dressing changes. The advanced multi-layer design helps provide high breathability to reduce the risk of maceration and protects against external bacteria.
Catalog Number
45330
Brand Name
Areza Medical
Version/Model Number
45330
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
f36547d1-222b-41f4-a56f-bbb885b1d4ee
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 |