RF Electrode

GUDID 00817371020069

Reusable Non-Invasive RF Electrode

Thermi

Medium-wave diathermy treatment system electrode, active

• Primary Device ID: 00817371020069
• NIH Device Record Key: c33db37f-abda-4a65-b95d-9c3f643ef0ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RF Electrode
• Version Model Number: RFE-10-D
• Company DUNS: 021008486
• Company Name: Thermi
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817371020069 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-13
• Device Publish Date: 2016-09-23

On-Brand Devices [RF Electrode]

• 00817371020274: Reusable Non-Invasive RF Electrode
• 00817371020069: Reusable Non-Invasive RF Electrode