Duns Number:080240553
Device Description: The HemCon ChitoDot is a bandage manufactured from chitosan. When applied directly to the The HemCon ChitoDot is a bandage manufactured from chitosan. When applied directly to the wound, the HemCon ChitoDot controls bleeding. The HemCon ChitoDot offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE), and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
Catalog Number
1093
Brand Name
HemCon ChitoDot®, 3/4in
Version/Model Number
1
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
K150916,K150916,K150916
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
fad22f8b-0aab-40c2-89f9-75f45e0df8d6
Public Version Date
April 22, 2021
Public Version Number
1
DI Record Publish Date
April 14, 2021
Package DI Number
20870053000043
Quantity per Package
50
Contains DI Package
00870053000049
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| U | Unclassified | 6 |