Duns Number:303655286
Device Description: More-Cell Bag is intended for use as a tissue containment system during minimally invasive More-Cell Bag 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.
Catalog Number
MCS5531
Brand Name
More-Cell Bag
Version/Model Number
MCS5531
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K212659,K212659
Product Code
PMU
Product Code Name
Containment System, Laparoscopic Power Morcellation, With Instrument Port
Public Device Record Key
59857c68-12b0-4cd5-b458-c62414fc90bf
Public Version Date
December 17, 2021
Public Version Number
1
DI Record Publish Date
December 09, 2021
Package DI Number
EAMIMCS55311
Quantity per Package
10
Contains DI Package
EAMIMCS55310
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |