FDA.reportPublic FDA data

Injectable RF Electrode

Primary DI
00817371020243
Brand
Injectable RF Electrode
Company
Thermi
Model
V-5-5-20-B
Published
2017-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170116000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170116000Thermi Injectable RF ElectrodesThermi2017-03-13GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817371020243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817371020243008173710202438173710202430817371020243

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, single-useAn invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
021008486
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
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
00817371020298Injectable RF ElectrodesV-Starter2017-09-20
00817371020274RF ElectrodeRFE-15-D2018-02-02

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Primary DI, Brand, Company table
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