FDA.reportPublic FDA data

INTRAgen

Primary DI
8800020105035
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
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OUHSkin Resurfacing Rf Applicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690275362
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290016814675EndyMed Intensif 10 pack tips package ENDYMED MEDICAL LTDOUH2026-05-07
07290016814569PRO MAX, System, 110VENDYMED MEDICAL LTDOUH2025-11-17
08800016903140Max-25CLASSYS Inc.OUH2025-07-02
08800016903171Max-M25CLASSYS Inc.OUH2025-07-02
08800016903423Max-25CCLASSYS Inc.OUH2025-07-02
08800016903447Max-64CCLASSYS Inc.OUH2025-07-02
08800016903454Max-M25CCLASSYS Inc.OUH2025-07-02
08800016905045QUADESSY Set PackageCLASSYS Inc.OUH2025-07-02
08800016905052QUADESSY Main UnitCLASSYS Inc.OUH2025-07-02
08800016905069QUADESSY Deeplus hand pieceCLASSYS Inc.OUH2025-07-02
07290016814668PURE DentAENDYMED MEDICAL LTDOUH2024-11-06
08800016903683Secret PRO Set PackageCLASSYS Inc.OUH2024-10-31
08800016903690Secret PRO Main UnitCLASSYS Inc.OUH2024-10-31
08800016903706Secret PRO Articulated ArmCLASSYS Inc.OUH2024-10-31
08800016903713Secret PRO Scanner HandpieceCLASSYS Inc.OUH2024-10-31
08800016903720Secret PRO Needle HanpdieceCLASSYS Inc.OUH2024-10-31
08800016903737Secret PRO Bigger HandpieceCLASSYS Inc.OUH2024-10-31
08800016903744Secret PRO Smartcure HandpieceCLASSYS Inc.OUH2024-10-31
08800016903195Fraxis Duo 25Pin Needle TipCLASSYS Inc.OUH2024-10-30
08800016903294Secret RF Main UnitCLASSYS Inc.OUH2024-10-30
08800016903300Secret RF Bigger HandpieceCLASSYS Inc.OUH2024-10-30
08800016903317Secret RF Smartcure Applicator With ElectrodesCLASSYS Inc.OUH2024-10-30
08800016903331Secret RF Small HandpieceCLASSYS Inc.OUH2024-10-30
08800016903621Fraxis DUO Set PackageCLASSYS Inc.OUH2024-10-30
08800016903638Fraxis Duo Main UnitCLASSYS Inc.OUH2024-10-30
08800016903645Fraxis Duo Articulated armCLASSYS Inc.OUH2024-10-30
08800016903652Fraxis Duo Scanner HandpieceCLASSYS Inc.OUH2024-10-30
08800016903669Fraxis Duo Needle HandpieceCLASSYS Inc.OUH2024-10-30
08800016903287Secret RF Set PackageCLASSYS Inc.OUH2024-10-25
07290016814408EndyMed PRO MAX, System, 110VENDYMED MEDICAL LTDOUH2024-05-16