More-Cell-System

FDA UDI

Class II (US FDA UDI)

by AMI Agency for Medical Innovations GmbH

Identity

Trade Name: More-Cell-System FDA UDI
Generic Name: Tissue extraction bag FDA UDI
Device Name: 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. FDA UDI
Model / Reference: MCS5511 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: MCS5511 FDA UDI
Primary DI / UDI-DI: EAMIMCS55110 FDA UDI
510(k) Number: K212659 FDA UDI
FDA Product Code: PMU FDA UDI
GMDN Term: Tissue extraction bag FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.4050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tissue extraction bag

More-Cell-System by AMI Agency for Medical Innovations GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K212659 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: AMI Agency for Medical Innovations GmbH

Sources (1)

FDA UDI 650419cc-0d79-4f46-9838-2f3a24e15234 36 fields · synced May 30, 2026