ThermiRF ThermiRF

GUDID 00817771029051

Thermi RF Radiofrequency Temp Controlled Generator

Celling Biosciences

Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator

• Primary Device ID: 00817771029051
• NIH Device Record Key: 08ba8c25-c569-45a5-a933-944da88cb5ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermiRF
• Version Model Number: ThermiRF
• Catalog Number: ThermiRF
• Company DUNS: 021560394
• Company Name: Celling Biosciences
• Device Count: 1
• DM Exempt: true
• 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	00817771029051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130689

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: 2023-09-25
• Device Publish Date: 2023-09-17

Devices Manufactured by Celling Biosciences

• 00817771028962 - Thermi Disposable RF Electrode (Qty1): 2023-09-25 Thermi Disposable RF Electrode - 50W Qty 1
• 00817771028979 - Thermi Disposable RF Electrode (Qty 5): 2023-09-25 Thermi Disposable RF Electrode - 50W Qty 5
• 00817771028986 - Thermi Disposable RF Electrode (Qty 1): 2023-09-25 Thermi Disposable RF Electrode - Qty 1
• 00817771028993 - Thermi Disposable RF Electrode (Qty 5): 2023-09-25 Thermi Disposable RF Electrode - Qty 5
• 00817771029006 - Reusable connector cable for disposable electrodes: 2023-09-25 Reusable connector cable for disposable electrodes
• 00817771029013 - RF Disposable Grounding Pad: 2023-09-25 RF Disposable Grounding Pad Qty 20
• 00817771029020 - Thermi Disposable RF Electrode (Qty 1): 2023-09-25 Thermi Disposable RF Electrode - Qty 1
• 00817771029037 - Thermi Disposable RF Electrode (Qty 5): 2023-09-25 Thermi Disposable RF Electrode - Qty 5