Duns Number:047724226
Device Description: Sacral Dressing Ultra-Absorbent Silicone Foam with Adhesive Border and Flaps 7.2" x 7.8" B Sacral Dressing Ultra-Absorbent Silicone Foam with Adhesive Border and Flaps 7.2" x 7.8" Box of 10
Catalog Number
SSF7810
Brand Name
Areza Medical
Version/Model Number
SSF7810
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
43981aa3-6fe4-4baa-b16e-6a823da1f2c7
Public Version Date
November 29, 2021
Public Version Number
1
DI Record Publish Date
November 20, 2021
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 |