JET-TIP

GUDID 08809295142554

RF Medical Co.,Ltd.

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

• Primary Device ID: 08809295142554
• NIH Device Record Key: 97e31055-b36f-4b52-be26-e221bc5a896a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JET-TIP
• Version Model Number: JET 1515B
• 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	08809295142554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193355

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: 2023-06-28
• Device Publish Date: 2023-06-20

On-Brand Devices [JET-TIP]

• 08809295142554: JET 1515B
• 08809295142547: JET 1510B