Thermi Disposable RF Electrode (Qty 1) RFDE-G1-20W-1

GUDID 00817771029471

Thermi Disposable RF Electrode - Qty 1 - Gen1 - 20W

Celling Biosciences

Medium-wave diathermy treatment system electrode, active

• Primary Device ID: 00817771029471
• NIH Device Record Key: 887ca53a-d6c7-4526-8163-87e4fccdaae3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermi Disposable RF Electrode (Qty 1)
• Version Model Number: RFDE-G1-20W-1
• Catalog Number: RFDE-G1-20W-1
• 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: true
• 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	00817771029471 [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 [Thermi Disposable RF Electrode (Qty 1)]

• 00817771029099: Thermi Disposable RF Electrode - Qty 1
• 00817771029020: Thermi Disposable RF Electrode - Qty 1
• 00817771028986: Thermi Disposable RF Electrode - Qty 1
• 00817771029471: Thermi Disposable RF Electrode - Qty 1 - Gen1 - 20W