Duns Number:532077389
Device Description: Copper impregnated antibactertial wound dressings designed to address a wide variety of wo Copper impregnated antibactertial wound dressings designed to address a wide variety of wounds including: diabetic wounds, leg & foot ulcers, pressure ulcers, first & second degree burns, surgical wounds; venous and arterial ulcers. External Size 4" x 10". Internal pad size 2" x 8"
Catalog Number
-
Brand Name
Antibacterial Wound Dressing with Copper with Adhesive Contour #2
Version/Model Number
2C-1025-01a
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180643,K180643
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
0ea286b1-1c20-4c82-bea9-377090506e4d
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
October 01, 2022
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 |
|---|---|---|
| U | Unclassified | 7 |