Duns Number:964438910
Device Description: NuMed Silver Bordered Foam 4x4 is made up of a PU Antibacterial polyurethane foam, polyvin NuMed Silver Bordered Foam 4x4 is made up of a PU Antibacterial polyurethane foam, polyvinyl alchohal, silver sulfate and silver chloride. It is a highly absorbent foam dressing with 0.35-0.40mg/cm3 ionic silver as the active component. This dressing provides an optimal moist wound healing enviroment, combining an effective antibacterial activity and is indicated for exudate absorption and the management of partial to full thickness wounds, including leg ulcers, pressure ulcers, diabetic foot ulcers, second-degree burns, donor sites, postoperative wounds, and skin abrasions.
Catalog Number
-
Brand Name
NuMed Industries LLC.
Version/Model Number
NM1010SBF
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140954,K140954
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
769b3503-45ce-4b05-804b-bebf28d6ff79
Public Version Date
September 23, 2022
Public Version Number
1
DI Record Publish Date
September 15, 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 | 10 |