AccessGUDID - DEVICE: More-Cell-System (EAMIMCS55110)

GUDID

Device Identifier (DI) Information

Brand Name: More-Cell-System
Version or Model: MCS5511
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCS5511
Company Name: AMI Agency for Medical Innovations GmbH

Primary DI Number: EAMIMCS55110
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 303655286 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45130	Tissue extraction bag	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PMU	Containment System, Laparoscopic Power Morcellation, With Instrument Port

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212659	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 650419cc-0d79-4f46-9838-2f3a24e15234
Public Version Date: December 17, 2021
Public Version Number: 1
DI Record Publish Date: December 09, 2021