AccessGUDID - DEVICE: Mara Console (00857379006023)

GUDID

Device Identifier (DI) Information

Brand Name: Mara Console
Version or Model: GEN-16-050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GEN-16-050
Company Name: AEGEA MEDICAL INC.

Primary DI Number: 00857379006023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825284834 *Terms of Use

Device Description: 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.

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:	No
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?
64808	Water vapour endometrial-ablation control unit	An electrically-powered device designed to regulate the pressure and temperature of water for its vaporization and subsequent application, via an attached applicator (not included), to ablate the interior lining of the uterus (endometrium) to treat dysfunctional uterine bleeding (menorrhagia). It is typically a unit consisting of a digital user-interface [e.g., liquid-crystal display (LCD)] and treatment setting controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNB	Device, Thermal Ablation, Endometrial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160047	006

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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