AccessGUDID - DEVICE: ATTIVA (08055510890087)

GUDID

Device Identifier (DI) Information

Brand Name: ATTIVA
Version or Model: MD01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ITALIAN ENGINEERING SRL

Primary DI Number: 08055510890087
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 431954955 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35156	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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220505	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Handling Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Weight: 5.8 Kilogram
Length: 38.5 Centimeter
Height: 10 Centimeter
Width: 20.5 Centimeter

Device Record Status

Public Device Record Key: 9667c2ee-94d3-463d-882c-4afb682fc65d
Public Version Date: March 28, 2023
Public Version Number: 1
DI Record Publish Date: March 20, 2023