VVR Generator

GUDID 08809306769244

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.

STARMED CO.,LTD

Percutaneous radio-frequency ablation system generator

• Primary Device ID: 08809306769244
• NIH Device Record Key: 7a308313-6470-4212-b184-e3c87669fba5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VVR Generator
• Version Model Number: VVR10
• Company DUNS: 694699723
• Company Name: STARMED CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809306769244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222997

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-08
• Device Publish Date: 2024-09-30

Devices Manufactured by STARMED CO.,LTD

• 08809306769244 - VVR Generator: 2024-10-08VVR 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.
• 08809306769244 - VVR Generator: 2024-10-08 VVR Generator System consists of Generator (VVR Generator), Active electrode (VENISTAR) and accessory such as foot switch and co
• 18809306764017 - VENISTAR: 2024-09-06
• 18809306764871 - VENISTAR: 2024-09-06
• 18809306767865 - VENISTAR: 2024-09-06
• 18809306767872 - VENISTAR: 2024-09-06
• 18809922260634 - ELRA Electrode: 2024-09-05
• 08809922260620 - ELRA Electrode: 2023-12-04
• 08809922260644 - ELRA Electrode: 2023-12-04