Mara Console GEN-16-050

GUDID 00857379006023

Circulating-fluid endometrial-ablation catheter

Primary Device ID	00857379006023
NIH Device Record Key	56ec49c7-f44d-47bd-9815-670a36bfdb3e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Mara Console
Version Model Number	GEN-16-050
Catalog Number	GEN-16-050
Company DUNS	825284834
Company Name	AEGEA MEDICAL INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00857379006023 [Primary]

MNB	Device, Thermal Ablation, Endometrial

Steralize Prior To Use	false
Device Is Sterile	false

00857379006023 - Mara Console	2020-03-24The 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.
00857379006023 - Mara Console	2020-03-24 The Mara Console guides the physician through the procedure by use of a graphical user interface; regulates the creation of wate
00857379006030 - Mara Water Vapor Probe Kit	2020-03-24 Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringe and saline s