Identity
- Trade Name
- Claritag Advanced FDA UDI
- Generic Name
- Wart-removal cryogenic kit FDA UDI
- Device Name
- Cryogenic Skin Tag Remover FDA UDI
- Model / Reference
- AZ-6055 FDA UDI
- Description
- Cryogenic Skin Tag Remover FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850001389167 FDA UDI
- 510(k) Number
- K222356 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
Category: Wart-removal cryogenic kit
Claritag Advanced by DGI Group LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wart-removal cryogenic kit.
- Dr Yglo — TheOTCLab B.V. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Freeze Away Dual Action 8ct — SCHOLL'S WELLNESS COMPANY · Class II
- Meijer — MEIJER, INC. · Class II
- Dr Scholls Freeze Away 7ct Blue — SCHOLL'S WELLNESS COMPANY · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Compound W® — MEDTECH PRODUCTS, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K222356 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
- DGI Group LLC
Sources (1)
- FDA UDI 26540888-5c47-4e99-ac71-5899bc41c246 34 fields · synced Jun 8, 2026