RFDE-VA RFDE-VA-1

GUDID 00817371020052

RFDE-VA Disposable Radio Frequency Electrode

Thermi

Medium-wave diathermy treatment system electrode, active
Primary Device ID00817371020052
NIH Device Record Key673e8710-a4a8-4a22-9a7b-3035edad5c99
Commercial Distribution StatusIn Commercial Distribution
Brand NameRFDE-VA
Version Model NumberRFDE-VA
Catalog NumberRFDE-VA-1
Company DUNS021008486
Company NameThermi
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817371020052 [Primary]
GS110817371020097 [Package]
Package: Box [5 Units]
In Commercial Distribution

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 Number5
Public Version Date2018-10-15
Device Publish Date2016-09-23

Devices Manufactured by Thermi

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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

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