Identity
- Trade Name
- HemCon® OneStop™ Vascular FDA UDI
- Generic Name
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
- Device Name
- The OneStop™ Vascular 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The OneStop™ Vascular 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. FDA UDI
Identifiers
- Catalog Number
- 1102 FDA UDI
- Primary DI / UDI-DI
- 00870053000322 FDA UDI
- FDA Product Code
- QSY FDA UDI
- GMDN Term
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chitosan haemostatic agent, professional, non-bioabsorbable
HemCon® OneStop™ Vascular by Tricol Biomedical, INC. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Axiostat Gauze — Advamedica, Inc. · U
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Tricol Biomedical, INC.
Sources (1)
- FDA UDI 79b811d1-0a8b-495c-bd76-a043ac13c9be 36 fields · synced May 30, 2026