Identity
- Trade Name
- ICEOUT™ FDA UDI
- Generic Name
- Cryogenic spray, cutaneous FDA UDI
- Device Name
- ICEOUT PORTABLE CRYOSURGICAL SYSTEM, (2) 80 ML AEROSOL DISPENSERS AND (60) 2MM & 5 MM APPLICATORS FDA UDI
- Model / Reference
- CRY25 FDA UDI
- Description
- ICEOUT PORTABLE CRYOSURGICAL SYSTEM, (2) 80 ML AEROSOL DISPENSERS AND (60) 2MM & 5 MM APPLICATORS FDA UDI
Identifiers
- Catalog Number
- CRY25 FDA UDI
- Primary DI / UDI-DI
- 10607151012127 FDA UDI
- 510(k) Number
- K152203 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- Cryogenic spray, cutaneous 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
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: Cryogenic spray, cutaneous
Iceout™ by Bovie Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152203 also covers:
- ICEOUT™ — BOVIE MEDICAL CORPORATION
- ICEOUT™ — BOVIE MEDICAL CORPORATION
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
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
- Bovie Medical Corporation
Sources (1)
- FDA UDI 001bbeb3-d70d-4ea6-b077-81c9bc617445 36 fields · synced Jun 8, 2026