FDA.reportPublic FDA data

INTRAgen

Primary DI
08800020105011
Brand
INTRAgen
Company
Jeisys Medical Inc.
Model
INTRAgen
Device description
Electrosurgical unit
Published
2016-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
8800020105035PackageGS11In Commercial Distribution
08800020105011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
8800020105035088000201050358800020105035
08800020105011088000201050118800020105011

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800020110688INTRAGen HandpieceINTRAGen Handpiece2026-07-29
08800020100153LIPOcelLIPOcel2026-07-21
08800020100481POTENZA TipCP-21 TIP2026-07-21
08800020101754POTENZA HandpieceAC Handpiece2026-07-21
08800020101761POTENZA HandpieceS Handpiece2026-07-21
08800020101778POTENZA HandpieceMotor Handpiece2026-07-21
08800020101891FootswitchLIPOcel_Foot Switch2026-07-21
08800020109088LIPOcel CartridgeL13 Cartridge2026-07-21
08800020109439TRI-BEAM ARMTRI-BEAM Articulated Arm 022026-07-21
08800020110541INTRAcel PremiumINTRAcel Premium Fractional RF Micro Needle (FRM) 2026-07-21
08800020111845P-NAIN SYSTEMP-NAIN SYSTEM2026-07-21
08800020111852HILTHERAHILTHERA 4.02026-07-21
08800020101211INTRAgen TipKT-152022-03-29
08800020105028INTRAgen TipKT-072016-10-31
08800020100276INTRAcel TipINTRAcel Tip 10102026-07-16
08800020100283INTRAcel TipINTRAcel Tip 32026-07-16
08800020100306INTRAcel TipINTRAcel Tip 10122026-07-16
08800020100313INTRAcel TipINTRAcel Tip 10132026-07-16
08800020100320INTRAcel TipINTRAcel Tip 20112026-07-16
08800020100337INTRAcel TipN16 Tip2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433062MillenniumAvalign Technologies, Inc.GEI2026-10-01
10884521740150LigaSureCovidien LPGEI2026-10-01
00190776432980MillenniumAvalign Technologies, Inc.GEI2026-09-30
B382SD070823101310Surgical DirectSurgical Direct, Inc.GEI2026-09-30
10884450452353STAR™Merit Medical Systems, Inc.GEI2026-09-29
00190776432645MillenniumAvalign Technologies, Inc.GEI2026-09-28
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21