More-Cell-System

Primary DI
EAMIMCS55110
Brand
More-Cell-System
Company
AMI Agency for Medical Innovations GmbH
Model
MCS5511
Catalog number
MCS5511
Device description
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.
Published
2021-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PMUContainment System, Laparoscopic Power Morcellation, With Instrument Port

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMUContainment System, Laparoscopic Power Morcellation, With Instrument PortObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212659000More-Cell-SystemAgency For Medical Innovations GmbH2021-11-10PMU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
MCS55111PackageHIBCC10In Commercial Distribution
EAMIMCS55110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
303655286
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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
07290118830023LapBox PowerARK SURGICAL LTDPMU2025-06-17
EAMIMCS55310More-Cell BagAMI Agency for Medical Innovations GmbHPMU2021-12-09
EAMIMCS55510More-Cell-System 30AMI Agency for Medical Innovations GmbHPMU2021-12-09
EAMIMCS55311More-Cell BagAMI Agency for Medical Innovations GmbHPMU2021-12-09
MCS55511More-Cell-System 30AMI Agency for Medical Innovations GmbHPMU2021-12-09
05391530440004PneumoLinerADVANCED SURGICAL CONCEPTS LIMITEDPMU2016-09-19
05391530440011PneumoLinerADVANCED SURGICAL CONCEPTS LIMITEDPMU2016-09-19