Duns Number:073189370
Device Description: Silver-sept® Antimicrobial Skin and Wound Gel, containing 200ug/gram total silver, is a cl Silver-sept® Antimicrobial Skin and Wound Gel, containing 200ug/gram total silver, is a clear amorphous hydrogel wound dressing. Silver-sept will not stain or discolor tissue. Silver-sept® gel functions as a long-lasting antimicrobial barrier by inhibiting the growth of common bacteria such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens including the antibiotic resistant strains Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE) as well as fungi such as Candida albicans and Aspergillus niger.
Catalog Number
3015S
Brand Name
Silver-sept Silver Antimicrobial Skin and Wound Gel
Version/Model Number
3015S
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062212,K062212
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
33255a1b-2dc5-4b81-b821-5165d382dd09
Public Version Date
December 01, 2020
Public Version Number
1
DI Record Publish Date
November 23, 2020
Package DI Number
00367180312157
Quantity per Package
12
Contains DI Package
00367180300154
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| U | Unclassified | 3 |