Duns Number:017524666
Device Description: Wound Free - Super Absorbent Non-adhesive Dressing (10x15cm) / 4"x6". Sterile.
Catalog Number
SAD-4x6
Brand Name
Wound Free
Version/Model Number
SAD-4x6
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
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
afa8fff4-884e-4c55-9d6e-786dc71d85fe
Public Version Date
May 27, 2022
Public Version Number
1
DI Record Publish Date
May 19, 2022
Package DI Number
10814639024750
Quantity per Package
10
Contains DI Package
00814639024753
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 |