MYOBLATE

GUDID 08809295147283

RF Medical Co.,Ltd.

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

• Primary Device ID: 08809295147283
• NIH Device Record Key: cbcc452e-0017-4f4c-897a-85804df816f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MYOBLATE
• Version Model Number: VCTM 10XXB
• 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	08809295147283 [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: 2023-10-31
• Device Publish Date: 2023-10-23

On-Brand Devices [MYOBLATE]

• 08809295147320: VCTM 35XXB
• 08809295147313: VCTM 30XXB
• 08809295147306: VCTM 25XXB
• 08809295147290: VCTM 15XXB
• 08809295147283: VCTM 10XXB
• 08809295147160: VCTM 20XXB