FDA.reportPublic FDA data

RF Electrode

Primary DI
00817371020274
Brand
RF Electrode
Company
Thermi
Model
RFE-15-D
Device description
Reusable Non-Invasive RF Electrode
Published
2018-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817371020274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817371020274008173710202748173710202740817371020274

GMDN Terms#

Term, Definition table
TermDefinition
Medium-wave diathermy treatment system electrode, activeA hand-operated electrical conductor that is a component of a medium-wave diathermy treatment system and designed to be moved over the skin surface of a patient by an operator to deliver an electrical current at a pre-set frequency to develop heat in subcutaneous tissues. It is typically designed with permanently attached cables. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021008486
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817371020618ThermiRF+ThermiRF+2022-09-05
00817371020359ARVATIARVATI2021-09-22
00817371020014ThermiRFThermiRF2016-09-23
00817371020021ThermiSmoothThermiSmooth 202016-09-23
00817371020038ThermiVAThermiVa2016-09-23
00817371020045ThermiEyesThermiEyes2016-09-23
00817371020052RFDE-VARFDE-VARFDE-VA-12016-09-23
00817371020069RF ElectrodeRFE-10-D2016-09-23
00817371020113Thermi Classic Radiofrequency Cannula S-505-B-202018-02-08
00817371020212Injectable RF ElectrodeV-10-10-18-B2017-09-20
00817371020229Injectable RF ElectrodeV-15-10-18-B2017-09-20
00817371020236Injectable RF ElectrodeV--20-10-16-B2017-09-20
00817371020243Injectable RF ElectrodeV-5-5-20-B2017-09-20
00817371020298Injectable RF ElectrodesV-Starter2017-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26