Duns Number:017524666
Device Description: Wound Free Foam Wound Dressing with Silicone adhesive border , 4X4". Sterile.
Catalog Number
FMD-S4
Brand Name
Wound Free
Version/Model Number
FMD-S4
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)
-
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
664a3ca3-28ac-461a-9609-5f4989ecee6d
Public Version Date
May 31, 2022
Public Version Number
1
DI Record Publish Date
May 23, 2022
Package DI Number
10814639024163
Quantity per Package
10
Contains DI Package
00814639024166
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 121 |