Duns Number:080240553
Device Description: The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the dressing controls bleeding. The 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
1114
Brand Name
HemCon® OneStop™ Bandage, 2in x 2in
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
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
40e4823f-261b-4d16-bd0e-270460b6f52b
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
October 15, 2020
Package DI Number
50870053000358
Quantity per Package
50
Contains DI Package
00870053000353
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| U | Unclassified | 6 |