RF THERMOCOUPLE ELECTRODE
- Primary DI
- 05060224334010
- Brand
- RF THERMOCOUPLE ELECTRODE
- Company
- ITALIAN ENGINEERING SRL
- Model
- RFEL-R200-IE
- Device description
- The electrode thermocouple measures temperature and, through a feedback circuit, automatically adjusting energy delivery to maintain the set temperature in the tissue. To be used with ATTIVA device (K220505).
- Published
- 2023-03-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K220505 | 000 | ATTIVA | Italian Engineering S.R.L. | 2023-02-09 | GEI |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05060224334010 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05060224334010 | 05060224334010 | 5060224334010 |
GMDN Terms
| Term | Definition |
|---|
| Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable | A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under x-ray, ultrasound (US) or other external image guidance] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula may be included. This is a reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Catheter Length | 200 | Millimeter |
Regulatory Flags
- DUNS number
- 431954955
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 08055510890131 | RF BLUNT STRAIGHT CANNULA, 22Gx100mm, ACTIVE TIP 10mm (w holder) | RF0M22100R10A | | 2023-08-04 |
| 05060224333983 | RF THERMOCOUPLE ELECTRODE | RFEL-R50-IE | | 2023-03-28 |
| 05060224333990 | RF THERMOCOUPLE ELECTRODE | RFEL-R100-IE | | 2023-03-28 |
| 05060224334003 | RF THERMOCOUPLE ELECTRODE | RFEL-R150-IE | | 2023-03-28 |
| 08058341213919 | RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w holder) | RF0MXXYYYRZZA | | 2023-03-28 |
| 08058341218716 | RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w/o Holder) | RF0MXXYYYRZZ | | 2023-03-28 |
| 05060224334072 | INTERMEDIATE CABLE | CBEL-R-IE | | 2023-03-20 |
| 08055510890087 | ATTIVA | MD01 | | 2023-03-20 |
Other Devices Sharing Product Codes