AccessGUDID - DEVICE: RFT Electrode (08809559960290)

GUDID

Device Identifier (DI) Information

Brand Name: RFT Electrode
Version or Model: RFTP-0707LN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RF Medical Co.,Ltd.

Primary DI Number: 08809559960290
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690514869 *Terms of Use

Device Description: The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit.

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:	Yes
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?
61933	Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar	A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) guidance] to deliver radio-frequency current in a monopolar configuration from a system generator to coagulate/ablate tissues (excluding the CNS and heart) for the treatment of tumours (e.g., in the liver); in addition to percutaneous access it might also be intended for laparoscopic and/or open surgical use. It includes one or more distal monopolar electrode(s) which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use 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 [?]
K180999	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Humidity: between 45 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Catheter Length: 7 Centimeter
Catheter Working Length: 7 Millimeter

Device Record Status

Public Device Record Key: 4d09c1e5-d904-4156-a87a-3bd5b322c304
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: September 30, 2019