Duns Number:080240553
Device Description: The OneStop™ Vascular is a wound dressing manufactured from chitosan. When applied directl
Catalog Number
1102
Brand Name
HemCon® OneStop™ Vascular
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
79b811d1-0a8b-495c-bd76-a043ac13c9be
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
September 22, 2020
Package DI Number
20870053000326
Quantity per Package
10
Contains DI Package
00870053000322
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
U | Unclassified | 6 |