Duns Number:825284834
Device Description: The Mara Console guides the physician through the procedure by use of a graphical user int The Mara Console guides the physician through the procedure by use of a graphical user interface; regulates the creation of water vapor in the Water Vapor Probe; and provides automated real-time monitoring and active management throughout the procedure.
Catalog Number
GEN-16-050
Brand Name
Mara Console
Version/Model Number
GEN-16-050
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
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
P160047
Product Code
MNB
Product Code Name
Device, Thermal Ablation, Endometrial
Public Device Record Key
56ec49c7-f44d-47bd-9815-670a36bfdb3e
Public Version Date
July 30, 2020
Public Version Number
3
DI Record Publish Date
March 16, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 2 |