Identity
- Trade Name
- Dr Yglo FDA UDI
- Generic Name
- Wart-removal cryogenic kit FDA UDI
- Device Name
- Dr Yglo Wart and Plantar Wart Remover FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Dr Yglo Wart and Plantar Wart Remover FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720618589002 FDA UDI
- 510(k) Number
- K210529 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Category: Wart-removal cryogenic kit
Dr Yglo by TheOTCLab B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K210529 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TheOTCLab B.V.
Sources (1)
- FDA UDI d882d481-0b35-482d-8eee-1d2ad4e72e20 34 fields · synced Jun 8, 2026