Identity
- Trade Name
- TopCare FDA UDI
- Generic Name
- Wart-removal cryogenic kit FDA UDI
- Device Name
- One Step Wart Freezer FDA UDI
- Model / Reference
- 003680041112 FDA UDI
- Description
- One Step Wart Freezer FDA UDI
Identifiers
- Catalog Number
- 003680041112 FDA UDI
- Primary DI / UDI-DI
- 00036800411128 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- Wart-removal cryogenic kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 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
Dimensions & Sizes
- Size
- Height — 155 Millimeter FDA UDI
Category: Wart-removal cryogenic kit
TopCare by Topco Associates, LLC — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Topco Associates, LLC
Sources (1)
- FDA UDI cf338b47-e130-419f-bceb-42c0de7426bc 37 fields · synced May 30, 2026