FDA.reportPublic FDA data

INTRAgen Tip

Primary DI
08800020105028
Brand
INTRAgen Tip
Company
Jeisys Medical Inc.
Model
KT-07
Device description
Sterile electrode
Published
2016-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
OUHSkin Resurfacing Rf Applicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
OUHSkin Resurfacing Rf ApplicatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142833000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142833000INTRAGenJeisys Medical, Inc.2015-06-04OUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800020105025PackageGS110In Commercial Distribution
28800020105022PackageGS15In Commercial Distribution
08800020105028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880002010502518800020105025
2880002010502228800020105022
08800020105028088000201050288800020105028

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring system applicator tipA removable endpiece that is attached to a radio-frequency (RF) skin contouring system applicator (handpiece), used to regulate the delivery of RF energy to the patient during treatment. As a procedural safety measure, the device may permit the transfer of energy only when a correct surface contact is established. It may also be used to cool the skin and monitor its temperature to protect the epidermis during treatment. This is a single-use device.

Regulatory Flags#

DUNS number
690275362
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800020108333DENSITY TipClassic-B Tip2026-03-16
08800020108340DENSITY TipClassic-E Tip2026-03-16
08800020108357DENSITY TipClassic-F Tip2026-03-16
08800020108364DENSITY TipHigh-B Tip2026-03-16
08800020108371DENSITY TipHigh-E Tip2026-03-16
08800020108388DENSITY TipHigh-F Tip2026-03-16
08800020101525POTENZANeutral Electrode Pad Cable2026-03-16
08800020108166DENSITYFoot switch2026-03-16
08800020108173DENSITYPower cord2026-03-16
08800020108180DENSITYNeutral Electrode Pad cable2026-03-16
08800020108197DENSITYHandpiece holder2026-03-16
08800020108203DENSITYHandpiece cradle2026-03-16
08800020108289DENSITY TipClassic-B Tip2026-03-16
08800020108272DENSITY TipClassic-E Tip2026-03-16
08800020108296DENSITY TipClassic-F Tip2026-03-16
08800020108302DENSITY TipHigh-B Tip2026-03-16
08800020108319DENSITY TipHigh-E Tip2026-03-16
08800020108326DENSITY TipHigh-F Tip2026-03-16
08800020108395POTENZAFoot Switch2026-03-16
08800020108401POTENZAPower Cable2026-03-16

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