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RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w holder)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w holder) FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
- Device Name
- RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm with Holder. This includes: - RF0M22050R10A - RF0M22100R10A - RF0M20150R10A - RF0M16200R10A. Cannulas are closed-end tip, so that the electrodes are never in contact with the patient as they are internal to the closed-end tip cannulas. To be used only with ATTIVA device (K220505). FDA UDI
- Model / Reference
- RF0MXXYYYRZZA FDA UDI
- Description
- RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm with Holder. This includes: - RF0M22050R10A - RF0M22100R10A - RF0M20150R10A - RF0M16200R10A. Cannulas are closed-end tip, so that the electrodes are never in contact with the patient as they are internal to the closed-end tip cannulas. To be used only with ATTIVA device (K220505). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08058341213919 FDA UDI
- 510(k) Number
- K220505 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Percutaneous radio-frequency ablation probe cannula, single-use
RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w holder) by Italian Engineering Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous radio-frequency ablation probe cannula, single-use.
- OWL — Diros Technology, Inc. · Class II
- OWL — Diros Technology, Inc. · Class II
- RadiOpaque Radiofrequency Cannula — Avanos Medical, Inc. · Class II
- OWL — Diros Technology, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- RadiOpaque Radiofrequency Cannula — Avanos Medical, Inc. · Class II
- LCCS — Lccs Products Limited · Class II
- OWL — Diros Technology, Inc. · Class II
Cleared under the same submission
K220505 also covers:
- ATTIVA — ITALIAN ENGINEERING SRL
- INTERMEDIATE CABLE — ITALIAN ENGINEERING SRL
- RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w/o Holder) — ITALIAN ENGINEERING SRL
- RF BLUNT STRAIGHT CANNULA, 22Gx100mm, ACTIVE TIP 10mm (w holder) — ITALIAN ENGINEERING SRL
- RF THERMOCOUPLE ELECTRODE — ITALIAN ENGINEERING SRL
- RF THERMOCOUPLE ELECTRODE — ITALIAN ENGINEERING SRL
- RF THERMOCOUPLE ELECTRODE — ITALIAN ENGINEERING SRL
- RF THERMOCOUPLE ELECTRODE — ITALIAN ENGINEERING SRL
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
- Italian Engineering Srl
Sources (1)
- FDA UDI 6713929c-7da6-4ddf-bdf3-ef9cb96fddd7 34 fields · synced May 30, 2026