Soft Inserts

Primary DI
EAMIESI12101
Brand
Soft Inserts
Company
AMI Agency for Medical Innovations GmbH
Model
ESI1210
Catalog number
ESI1210
Published
2019-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
EAMIESI12101PackageHIBCC5In Commercial Distribution
EAMIESI12100PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
303655286
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
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
EAMIEAS13100EasyAct 3 SEAS1310EAS13102019-04-05
EAMIEAS13200EasyAct 3 MEAS1320EAS13202019-04-05
EAMIEAS15100EasyAct 5 SEAS1510EAS15102019-04-05
EAMIEAS15200EasyAct 5 MEAS1520EAS15202019-04-05
EAMIEAS15300EasyAct 5 LEAS1530EAS15302019-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998302718Solventumâ„¢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
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21