Identity
- Trade Name
- Hydrozid FDA UDI
- Generic Name
- Cryogenic spray, cutaneous FDA UDI
- Device Name
- Hydrozid, portable cryosurgery device, 200mL FDA UDI
- Model / Reference
- 101 FDA UDI
- Description
- Hydrozid, portable cryosurgery device, 200mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05744002420033 FDA UDI
- 510(k) Number
- K201740 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
Dimensions & Sizes
- Size
- Total Volume — 200 Milliliter FDA UDI
Category: Cryogenic spray, cutaneous
Hydrozid by BIBAWO Medical A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Cryo Professional — Koninklijke Utermöhlen N.V. · Class II
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
- BIBAWO Medical A/S
Sources (1)
- FDA UDI c60d380b-4686-4bfa-9402-733b550189e2 36 fields · synced Jun 9, 2026