ThermiRF ThermiSmooth

GUDID 00817771029655

Thermi RF Radiofrequency Temp Controlled Generator - ThermiSmooth

Celling Biosciences

Percutaneous radio-frequency ablation system generator

• Primary Device ID: 00817771029655
• NIH Device Record Key: 08792bba-a46a-43e9-ab36-bf5e3250dbf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermiRF
• Version Model Number: ThermiRF Smooth
• Catalog Number: ThermiSmooth
• 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	00817771029655 [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: 2025-04-21
• Device Publish Date: 2025-04-11

On-Brand Devices [ThermiRF]

• 00817771029051: Thermi RF Radiofrequency Temp Controlled Generator
• 00817771029723: Thermi RF Radiofrequency Temp Controlled Generator Previously Owned
• 00817771029655: Thermi RF Radiofrequency Temp Controlled Generator - ThermiSmooth
• 00817771029501: Thermi RF Radiofrequency Temp Controlled Generator - Thermi Eye
• 00817771029365: Thermi RF Radiofrequency Temp Controlled Generator - Thermi VA