ThermiSmooth

GUDID 00817371020021

ThermiSmooth Radiofrequency Generator

Thermi

Radio-frequency ablation system generator
Primary Device ID00817371020021
NIH Device Record Keye0174c21-ce79-4929-8394-786e7ddbc90c
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermiSmooth
Version Model NumberThermiSmooth 20
Company DUNS021008486
Company NameThermi
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817371020021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-09
Device Publish Date2016-09-23

Devices Manufactured by Thermi

00817371020618 - ThermiRF+2022-09-13 Thermi radio frequency generator
00817371020359 - ARVATI2021-09-30 Temperature Control Radiofrequency Generator
00817371020014 - ThermiRF2019-08-09 Thermi Radio Frequency Generator
00817371020021 - ThermiSmooth2019-08-09ThermiSmooth Radiofrequency Generator
00817371020021 - ThermiSmooth2019-08-09 ThermiSmooth Radiofrequency Generator
00817371020038 - ThermiVA2019-08-09 ThermiVa Radiofrequency Generator
00817371020045 - ThermiEyes2019-08-09 ThermiEyes Radiofrequency Generator
00817371020113 - Thermi Classic Radiofrequency Cannula 2019-02-07 Radiofrequency Cannula - Straight Blunt
00817371020212 - Injectable RF Electrode2019-02-07 Disposable Radiofrequency Cannula Electrode

Trademark Results [ThermiSmooth]

Mark Image

Registration | Serial
Company
Trademark
Application Date
THERMISMOOTH
THERMISMOOTH
87363555 5296382 Live/Registered
ThermiGen, LLC
2017-03-08
THERMISMOOTH
THERMISMOOTH
86260592 4621262 Live/Registered
ThermiGen, LLC
2014-04-23

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