ATTIVA
- Primary DI
- 08055510890087
- Brand
- ATTIVA
- Company
- ITALIAN ENGINEERING SRL
- Model
- MD01
- Device description
- ATTIVA is a Radiofrequency (RF) System (generator, electrodes/handpieces and accessories) indicated for treatments based on the emission of electromagnetic waves that lead to a rise of internal temperature of tissues involved in the treatment for electrocoagulation and hemostasis. ATTIVA device can be used on adult patients only. It comprises of a base unit, activation pedal, ground pad (K203494), endodermic handpiece, thermal camera (K033967) and monitor, and blunt cannulas and RF electrodes.
- Published
- 2023-03-20
- 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 |
|---|
| 08055510890087 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08055510890087 | 08055510890087 | 8055510890087 |
GMDN Terms
| Term | Definition |
|---|
| Percutaneous radio-frequency ablation system generator | An electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery). |
Device Sizes
| Type | Value | Unit |
|---|
| Height | 10 | Centimeter |
| Length | 38.5 | Centimeter |
| Weight | 5.8 | Kilogram |
| Width | 20.5 | Centimeter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Handling Environment Humidity | 30 Percent (%) Relative Humidity | 70 Percent (%) Relative Humidity | |
| Handling Environment Temperature | 15 Degrees Celsius | 35 Degrees Celsius | |
| Storage Environment Atmospheric Pressure | 50 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 20 Percent (%) Relative Humidity | 90 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -20 Degrees Celsius | 50 Degrees Celsius | |
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 |
| 05060224334010 | RF THERMOCOUPLE ELECTRODE | RFEL-R200-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 |
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