VIVA combo RF Generator VCS10

GUDID 08809306769060

The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation and ablation of tissue. The VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This generator monitors the power, resistance, current and temperature.

STARMED CO.,LTD

Radio-frequency ablation system generator

• Primary Device ID: 08809306769060
• NIH Device Record Key: 5c2afa92-5153-4476-a5b9-cc594c750f17
• Commercial Distribution Discontinuation: 2019-07-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VIVA combo RF Generator
• Version Model Number: VCS10
• Catalog Number: VCS10
• 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: false
• 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

Customer Support Contacts

• Phone: +82318163546
• Email: inquiry@starmed4u.com
• Phone: +82318163546
• Email: inquiry@starmed4u.com
• Phone: +82318163546
• Email: inquiry@starmed4u.com
• Phone: +82318163546
• Email: inquiry@starmed4u.com
• Phone: +82318163546
• Email: inquiry@starmed4u.com
• Phone: +82318163546
• Email: inquiry@starmed4u.com
• Phone: +82318163546
• Email: inquiry@starmed4u.com

Device Dimensions

• Width: 260 Millimeter
• Weight: 6 Kilogram
• Height: 115 Millimeter
• Length: 348 Millimeter
• Width: 260 Millimeter
• Weight: 6 Kilogram
• Height: 115 Millimeter
• Length: 348 Millimeter
• Width: 260 Millimeter
• Weight: 6 Kilogram
• Height: 115 Millimeter
• Length: 348 Millimeter
• Width: 260 Millimeter
• Weight: 6 Kilogram
• Height: 115 Millimeter
• Length: 348 Millimeter
• Width: 260 Millimeter
• Weight: 6 Kilogram
• Height: 115 Millimeter
• Length: 348 Millimeter
• Width: 260 Millimeter
• Weight: 6 Kilogram
• Height: 115 Millimeter
• Length: 348 Millimeter
• Width: 260 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809306769060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163450

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-05
• Device Publish Date: 2017-05-19

On-Brand Devices [VIVA combo RF Generator]

• 08809306769060: The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristalt
• 08809306769152: The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristalt