Identity
- Trade Name
- More-Cell-System 30 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 surgeryto enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for powermorcellation and removal. FDA UDI
- Model / Reference
- MCS5551 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- MCS5551 FDA UDI
- Primary DI / UDI-DI
- EAMIMCS55510 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tissue extraction bag
More-Cell-System 30 by AMI Agency for Medical Innovations GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue extraction bag.
- Alexis® Contained Extraction System — APPLIED MEDICAL RESOURCES CORP. · Class II
- SimplyStrong — Genicon · Class II
- Monopolar posts long for handles — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- DR. POYNTER MC — APPLIED MEDICAL RESOURCES CORP. · Class II
- DR.BRIZENDINE LAP CHOLECYSTECTOMY — APPLIED MEDICAL RESOURCES CORP. · Class I
- GeniStrong — Genicon · Class II
- TOTAL 5mm SOLUTION KIT 11 — APPLIED MEDICAL RESOURCES CORP. · Class II
- PARTNERS LC KIT 006 — APPLIED MEDICAL RESOURCES CORP. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AMI Agency for Medical Innovations GmbH
Sources (1)
- FDA UDI ce0e1ef2-e826-4ca8-b655-0c4cf7947436 36 fields · synced May 30, 2026