THYBLATE-V™

GUDID 08800142919213

RF Medical Co.,Ltd.

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

• Primary Device ID: 08800142919213
• NIH Device Record Key: bf7145d1-8b58-4d76-a5f8-c3f784e9e7f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THYBLATE-V™
• Version Model Number: RFTVO 07XXV
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800142919213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232763

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-01
• Device Publish Date: 2023-10-24

On-Brand Devices [THYBLATE-V™]

• 08800142919190: RFTV 07XXV
• 08800142919220: RFTVO 10XXV
• 08800142919213: RFTVO 07XXV
• 08800142919206: RFTV 10XXV