Duns Number:080240553
Device Description: The HemCon Bandage PRO is a wound dressing manufactured from chitosan. When applied direct The HemCon Bandage PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon Bandage PRO controls bleeding caused by external trauma. The HemCon Bandage PRO 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
1003
Brand Name
HemCon® Bandage PRO, 4in x 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
K080818,K080818,K080818
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
b3067cf7-e600-424e-b660-e7b09e0df4f1
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
October 14, 2020
Package DI Number
20870053001019
Quantity per Package
5
Contains DI Package
00870053001015
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| U | Unclassified | 6 |