FDA.reportPublic FDA data

EasyAct 3 S

Primary DI
EAMIEAS13100
Brand
EasyAct 3 S
Company
AMI Agency for Medical Innovations GmbH
Model
EAS1310
Catalog number
EAS1310
Published
2019-04-05
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182013000EasyInstrumentsAgency For Medical Innovations GmbH2019-03-11GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EAMIEAS13100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, reusableA hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during argon-enhanced electrosurgery. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3Millimeter
Shaft Length170Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
303655286
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EAMIRAR20810RAR Flexi ProbeRAR2081RAR20812018-11-28
EAMIICT50100i-Cut Power SupplyICT50102025-05-05
EAMIICT50110i-CutICT5011ICT50112025-05-05
EAMIICT50500i-Cut Power Supply Type AICT50502025-05-05
EAMIECI10310A.M.I. EasyClinch Disposable Tips PremiumECI1031ECI10312019-04-05
EAMIECM10110EasyClinch microECM1011ECM10112019-04-05
EAMIEDI10310A.M.I. EasyDissect Disposable Tips PremiumEDI1031EDI10312019-04-05
EAMIEDI10510A.M.I. EasyHookEDI1051EDI10512019-04-05
EAMIEDM10110EasyDissect microEDM1011EDM10112019-04-05
EAMIESI11310A.M.I. EasyShear Disposable Tips PremiumESI1131ESI11312019-04-05
EAMIESI11510A.M.I. EasyShear Mini Disposable Tips PremiumESI1151ESI11512019-04-05
EAMIESI12100Soft InsertsESI1210ESI12102019-04-05
EAMIESM10110EasyShears microESM1011ESM10112019-04-05
EAMIEVI10110ViperEVI1011EVI10112019-04-05
EAMIEAH10100EasyAct HandleEAH1010EAH10102019-04-05
EAMIEAS13200EasyAct 3 MEAS1320EAS13202019-04-05
EAMIEAS15100EasyAct 5 SEAS1510EAS15102019-04-05
EAMIEAS15200EasyAct 5 MEAS1520EAS15202019-04-05
EAMIEAS15300EasyAct 5 LEAS1530EAS15302019-04-05
EAMIECA10200A.M.I. HF-Cable MartinECA1020ECA10202019-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00860015792006NOVOCLEAR™ DeviceAventix Medical Inc.GEI2026-06-09
00860015792013AVENTIX® PFX SystemAventix Medical Inc.GEI2026-06-09
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
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00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03