Identity
- Trade Name
- ClariFix FDA UDI
- Generic Name
- Nitrous oxide gas cartridge FDA UDI
- Device Name
- Cryogen Canister, 10ml FDA UDI
- Model / Reference
- CFX-0004 FDA UDI
- Description
- Cryogen Canister, 10ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868438000227 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- Nitrous oxide gas cartridge 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
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 — 10 Milliliter FDA UDI
Category: Nitrous oxide gas cartridge
ClariFix by Arrinex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrous oxide gas cartridge.
- CryoProbe — H & O Equipments SA · Class II
- Freezpen® — H & O Equipments SA · Class II
- Freezpen® — H & O Equipments SA · Class II
- FrostAway™ — H & O Equipments SA · Class II
- ClariFix — Stryker Corp. · Class II
- Freezpen — H & O Equipments SA · Class II
- CryoProbe™ — H & O Equipments SA · Class II
- CryoProbe — H & O Equipments SA · 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
- Arrinex, Inc.
Sources (1)
- FDA UDI 0fe584d9-df6d-4457-9352-29fd44ed93c0 36 fields · synced Jun 8, 2026