RF ABLATION SYSTEM V-1000

GUDID 08809295147030

The RF Ablation System V-1000 is a microprocessor-based generator. This generator provides up to 140 W of RF energy to be used for coagulation & ablation of vessel, tissue and bone.

RF Medical Co.,Ltd.

Percutaneous radio-frequency ablation system generator

• Primary Device ID: 08809295147030
• NIH Device Record Key: 3d4f8560-35de-4b1c-8c58-b912c885e9aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RF ABLATION SYSTEM V-1000
• Version Model Number: V-1000
• Company DUNS: 690514869
• Company Name: RF Medical 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

Customer Support Contacts

• Phone: +82221084200
• Email: overseas@rfa.co.kr
• Phone: +82221084200
• Email: overseas@rfa.co.kr
• Phone: +82221084200
• Email: overseas@rfa.co.kr
• Phone: +82221084200
• Email: overseas@rfa.co.kr
• Phone: +82221084200
• Email: overseas@rfa.co.kr
• Phone: +82221084200
• Email: overseas@rfa.co.kr

Device Dimensions

• Height: 226 Millimeter
• Depth: 391 Millimeter
• Width: 322 Millimeter
• Weight: 13 Kilogram
• Height: 226 Millimeter
• Depth: 391 Millimeter
• Width: 322 Millimeter
• Weight: 13 Kilogram
• Height: 226 Millimeter
• Depth: 391 Millimeter
• Width: 322 Millimeter
• Weight: 13 Kilogram
• Height: 226 Millimeter
• Depth: 391 Millimeter
• Width: 322 Millimeter
• Weight: 13 Kilogram
• Height: 226 Millimeter
• Depth: 391 Millimeter
• Width: 322 Millimeter
• Weight: 13 Kilogram
• Height: 226 Millimeter
• Depth: 391 Millimeter
• Width: 322 Millimeter
• Weight: 13 Kilogram

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809295147030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180999

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: 3
• Public Version Date: 2022-06-10
• Device Publish Date: 2019-07-31

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• 08800142906565 - BIG-TIP™: 2025-09-15
• 08800142906572 - BIG-TIP™: 2025-09-15