Duns Number:238476068
Device Description: Antibacterial Burn Dressing: For the Pre-Hospital Management of 1st and 2nd Degree Burns w Antibacterial Burn Dressing: For the Pre-Hospital Management of 1st and 2nd Degree Burns with Aquanova Ag TechnologyEach dressing contains nominally 0.75% by weight of ionic silver
Catalog Number
FG08825191
Brand Name
SILVAPRO
Version/Model Number
FG08825191
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
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
821275c0-3ae4-4ff7-84fc-c91666cd6da2
Public Version Date
October 08, 2021
Public Version Number
1
DI Record Publish Date
September 30, 2021
Package DI Number
35060206630278
Quantity per Package
25
Contains DI Package
15060206630274
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| U | Unclassified | 14 |