More-Cell-System 30

Primary DI
MCS55511
Brand
More-Cell-System 30
Company
AMI Agency for Medical Innovations GmbH
Model
MCS5551
Catalog number
MCS5551
Device description
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgeryto enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for powermorcellation 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
OTC
false
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
MCS55511PackageHIBCC10In Commercial Distribution
EAMIMCS55510PrimaryHIBCC0

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
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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
EAMIMCS55110More-Cell-SystemAMI Agency for Medical Innovations GmbHPMU2021-12-09
EAMIMCS55311More-Cell BagAMI Agency for Medical Innovations GmbHPMU2021-12-09
05391530440004PneumoLinerADVANCED SURGICAL CONCEPTS LIMITEDPMU2016-09-19
05391530440011PneumoLinerADVANCED SURGICAL CONCEPTS LIMITEDPMU2016-09-19