Duns Number:073189370
Device Description: Anasept® Antimicrobial Skin and Wound Gel is a clear, amorphous hydrogel that helps mainta Anasept® Antimicrobial Skin and Wound Gel is a clear, amorphous hydrogel that helps maintain moist wound environment that is conducive to healing, by either absorbing wound exudate or donating moisture while delivering 0.057% broad spectrum antimicrobial sodium hypochlorite. Anasept® Gel inhibits the growth of microorganisms, such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, Acinetobacter baumannii, Clostridium difficile and antibiotic resistant strains such as Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE), Carbapenem resistant E.coli (CRE) that are commonly found in wound bed as well as fungi such as Aspergillus niger, Candida albicans and Candida auris.
Catalog Number
5003G
Brand Name
Anasept Antimicrobial Skin and Wound Gel
Version/Model Number
5003G
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
K073547,K073547
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
1033ad6a-3d15-4d47-aa90-240aea8b0043
Public Version Date
July 28, 2020
Public Version Number
2
DI Record Publish Date
July 06, 2020
Package DI Number
00367180512038
Quantity per Package
12
Contains DI Package
00367180500035
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 |