Identity
- Trade Name
- HemCon ChitoDot®, 3/4in FDA UDI
- Generic Name
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
- Device Name
- The HemCon ChitoDot is a bandage manufactured from chitosan. When applied directly to the wound, the HemCon ChitoDot controls bleeding. The HemCon ChitoDot 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 HemCon ChitoDot is a bandage manufactured from chitosan. When applied directly to the wound, the HemCon ChitoDot controls bleeding. The HemCon ChitoDot 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
- 1093 FDA UDI
- Primary DI / UDI-DI
- 00870053000049 FDA UDI
- FDA Product Code
- FRO 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 ChitoDot®, 3/4in by Tricol Biomedical, INC. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 fad22f8b-0aab-40c2-89f9-75f45e0df8d6 36 fields · synced Jun 6, 2026