Mygen™ RF Generator M-3004

GUDID 08809295147023

RF Medical Co.,Ltd.

Percutaneous radio-frequency ablation system generator

• Primary Device ID: 08809295147023
• NIH Device Record Key: bc3d6894-3976-41f3-b49e-492578ac03e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mygen™ RF Generator M-3004
• Version Model Number: M-3004
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809295147023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221277

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-15
• Device Publish Date: 2025-09-05

Devices Manufactured by RF Medical Co.,Ltd.

• 08800142906435 - BIG-TIP™: 2025-09-15
• 08800142906442 - BIG-TIP™: 2025-09-15
• 08800142906459 - BIG-TIP™: 2025-09-15
• 08800142906534 - BIG-TIP™: 2025-09-15
• 08800142906541 - BIG-TIP™: 2025-09-15
• 08800142906558 - BIG-TIP™: 2025-09-15
• 08800142906565 - BIG-TIP™: 2025-09-15
• 08800142906572 - BIG-TIP™: 2025-09-15