Thermi Reusable RF Electrode RFE-10-D-G2

GUDID 00817771029273

Thermi 10mm Reusable Non-Invasive RF Electrode

Celling Biosciences

Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active Medium-wave diathermy treatment system electrode, active

• Primary Device ID: 00817771029273
• NIH Device Record Key: aa0c0369-566c-4f23-bf50-291bbe888ec4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermi Reusable RF Electrode
• Version Model Number: RFE-10-D-G2
• Catalog Number: RFE-10-D-G2
• Company DUNS: 021560394
• Company Name: Celling Biosciences
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	00817771029273 [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

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• 00817771029075: Thermi 15mm Reusable Non-Invasive RF Electrode