AccessGUDID - DEVICE: VVR Generator (08809306769244)

GUDID

Device Identifier (DI) Information

Brand Name: VVR Generator
Version or Model: VVR10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STARMED CO.,LTD

Primary DI Number: 08809306769244
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 694699723 *Terms of Use

Device Description: VVR Generator System consists of Generator (VVR Generator), Active electrode (VENISTAR) and accessory such as foot switch and cooling pump. The generator generates, controls and monitors RF energy and delivers energy to the active electrode. The active electrode has an active coil and a receiver coil that allow the RF energy to flow through the tissue. The RF energy raises the temperature in the tissue, causing coagulation and occlusion of blood vessels. The single footswitch works as an on/off switch and the double footswitch works to increase or decrease the power output. A cooling pump circulates water around the electrodes to reduce the temperature of the electrodes and prevent tissue sticking to the 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 [?]
K222997	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
No Device Sizes

Device Record Status

Public Device Record Key: 7a308313-6470-4212-b184-e3c87669fba5
Public Version Date: October 08, 2024
Public Version Number: 1
DI Record Publish Date: September 30, 2024