THYBLATE™

GUDID 08800142923708

RF Medical Co.,Ltd.

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

• Primary Device ID: 08800142923708
• NIH Device Record Key: 33c3b62d-fb4f-4690-97af-0a3f5afc4dc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THYBLATE™
• Version Model Number: RFTSP 1004N
• 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	08800142923708 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-28
• Device Publish Date: 2023-08-18

On-Brand Devices [THYBLATE™]

• 08809559960146: RFTP 1015N
• 08800142923807: RFTSP 1015LN
• 08800142923791: RFTSP 1010LN
• 08800142923784: RFTSP 1007LN
• 08800142923777: RFTSP 1005LN
• 08800142923760: RFTSP 1004LN
• 08800142923753: RFTSP 1003LN
• 08800142923746: RFTSP 1015N
• 08800142923739: RFTSP 1010N
• 08800142923722: RFTSP 1007N
• 08800142923715: RFTSP 1005N
• 08800142923708: RFTSP 1004N
• 08800142923692: RFTSP 1003N