Identity
- Trade Name
- Verruca-Freeze FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Device Name
- Verruca-Freeze 120ml Kit FDA UDI
- Model / Reference
- TKIT FDA UDI
- Description
- Verruca-Freeze 120ml Kit FDA UDI
Identifiers
- Catalog Number
- TKIT FDA UDI
- Primary DI / UDI-DI
- 00865715000338 FDA UDI
- 510(k) Number
- K982506 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- General cryosurgical system, cryogen gas, mechanical 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 120 Milliliter FDA UDI
Category: General cryosurgical system, cryogen gas, mechanical
Verruca-Freeze by Cryosurgery, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General cryosurgical system, cryogen gas, mechanical.
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Cleared under the same submission
K982506 also covers:
- Verruca-Freeze — Cryosurgery, Inc.
- Verruca-Freeze — Cryosurgery, Inc.
- Verruca-Freeze — Cryosurgery, Inc.
- Verruca-Freeze — Cryosurgery, Inc.
- Verruca-Freeze — Cryosurgery, Inc.
- Verruca-Freeze — Cryosurgery, Inc.
- Verruca-Freeze — Cryosurgery, Inc.
- Verruca-Freeze — Cryosurgery, Inc.
- Verruca-Freeze — Cryosurgery, Inc.
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
- Cryosurgery, Inc.
Sources (1)
- FDA UDI 0055c0ac-9ad6-4cd2-ac44-a2a793b6dcf1 38 fields · synced Jun 1, 2026