ThermiSmooth

GUDID 00817371020021

ThermiSmooth Radiofrequency Generator

Thermi

Radio-frequency ablation system generator

• Primary Device ID: 00817371020021
• NIH Device Record Key: e0174c21-ce79-4929-8394-786e7ddbc90c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermiSmooth
• Version Model Number: ThermiSmooth 20
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817371020021 [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: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2016-09-23

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: 2019-08-09ThermiSmooth Radiofrequency 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