AccessGUDID - DEVICE: RF THERMOCOUPLE ELECTRODE (05060224334010)

GUDID

Device Identifier (DI) Information

Brand Name: RF THERMOCOUPLE ELECTRODE
Version or Model: RFEL-R200-IE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ITALIAN ENGINEERING SRL

Primary DI Number: 05060224334010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 431954955 *Terms of Use

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).

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?
62025	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.	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Length: 200 Millimeter

Device Record Status

Public Device Record Key: eb05ab35-9c19-465d-9a0c-721bd5f53b4f
Public Version Date: April 05, 2023
Public Version Number: 1
DI Record Publish Date: March 28, 2023