Injectable RF Electrodes

GUDID 00817371020298

Thermi

Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00817371020298
• NIH Device Record Key: 5afb740c-7e9c-4610-b280-ea28c17691a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Injectable RF Electrodes
• Version Model Number: V-Starter
• Company DUNS: 021008486
• Company Name: Thermi
• 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: false
• 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	00817371020298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170116

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00817371020298]

Radiation Sterilization

[00817371020298]

Radiation Sterilization

[00817371020298]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-09-20

Devices Manufactured by Thermi

• 00817371020618 - ThermiRF+: 2022-09-13 Thermi radio frequency generator
• 00817371020359 - ARVATI: 2021-09-30 Temperature Control Radiofrequency Generator
• 00817371020014 - ThermiRF: 2019-08-09 Thermi Radio Frequency Generator
• 00817371020021 - ThermiSmooth: 2019-08-09 ThermiSmooth Radiofrequency Generator
• 00817371020038 - ThermiVA: 2019-08-09 ThermiVa Radiofrequency Generator
• 00817371020045 - ThermiEyes: 2019-08-09 ThermiEyes Radiofrequency Generator
• 00817371020113 - Thermi Classic Radiofrequency Cannula: 2019-02-07 Radiofrequency Cannula - Straight Blunt
• 00817371020212 - Injectable RF Electrode: 2019-02-07 Disposable Radiofrequency Cannula Electrode