RFT Electrode

GUDID 08809559960139

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

RF Medical Co.,Ltd.

Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

• Primary Device ID: 08809559960139
• NIH Device Record Key: 68022836-a920-441b-ae45-1d1c223e3d9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RFT Electrode
• Version Model Number: RFTP-1010N
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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

• Catheter Working Length: 10 Millimeter
• Catheter Length: 10 Centimeter
• Catheter Working Length: 10 Millimeter
• Catheter Length: 10 Centimeter
• Catheter Working Length: 10 Millimeter
• Catheter Length: 10 Centimeter
• Catheter Working Length: 10 Millimeter
• Catheter Length: 10 Centimeter
• Catheter Working Length: 10 Millimeter
• Catheter Length: 10 Centimeter
• Catheter Working Length: 10 Millimeter
• Catheter Length: 10 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809559960139 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2019-08-29

On-Brand Devices [RFT Electrode]

• 08809559960290: The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit.
• 08809559960306: The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit.
• 08809559960283: The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit.
• 08809559960139: The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit.
• 08809559960078: The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit.
• 08809559960061: The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit.