Identity
- Trade Name
- TopCare FDA UDI
- Generic Name
- Chitosan haemostatic agent, home-use FDA UDI
- Device Name
- Antibacterial Rapid-Seal Wound Gel, 0.5 FL OZ (14 mL) FDA UDI
- Model / Reference
- 036800007659 FDA UDI
- Description
- Antibacterial Rapid-Seal Wound Gel, 0.5 FL OZ (14 mL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00036800007659 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Chitosan haemostatic agent, home-use FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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, home-use
TopCare by Topco Associates, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · U
- CELOX First Aid — Medtrade Products , Ltd. · 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
- Topco Associates, LLC
Sources (1)
- FDA UDI 0f3efc2a-e6d2-461f-8e62-34a2bf5ce05b 34 fields · synced May 30, 2026