Duns Number:303655286
Device Description: More-Cell-System is intended for use as a tissue containment system during minimally invas
Catalog Number
MCS5551
Brand Name
More-Cell-System 30
Version/Model Number
MCS5551
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
ce0e1ef2-e826-4ca8-b655-0c4cf7947436
Public Version Date
December 17, 2021
Public Version Number
1
DI Record Publish Date
December 09, 2021
Package DI Number
MCS55511
Quantity per Package
10
Contains DI Package
EAMIMCS55510
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 |