Duns Number:080240553
Device Description: The ChitoFlex PRO Hemostatic Dressing is manufactured from chitosan. When applied directly The ChitoFlex PRO Hemostatic Dressing is manufactured from chitosan. When applied directly to the wound, the ChitoFlex PRO Hemostatic Dressing controls bleeding caused by extreme trauma. The ChitoFlex PRO Hemostatic Dressing 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
1008
Brand Name
HemCon ChitoFlex®, 1in x 3in
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
K080818,K080818,K080818
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
10a44011-31c1-45fa-9f5e-c32260c5f2d3
Public Version Date
April 22, 2021
Public Version Number
1
DI Record Publish Date
April 14, 2021
Package DI Number
20870053001125
Quantity per Package
5
Contains DI Package
00870053001121
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| U | Unclassified | 6 |