AEGEA MEDICAL INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Thermal Ablation, Endometrial (MNB) (2)

Premarket Exempt

Clear

Mara Console - 00857379006023 Catalog Number : GEN-16-050

Device Description : The Mara Console guides the physician through the procedure by use of a graphica 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 Class : 3

Duns Number: 825284834

Premarket Exempt : No

Product Code : MNB

Prescription Use : Yes

Device Count : 1

Mara Water Vapor Probe Kit - 00857379006030 Catalog Number : DDK-16-050

Device Description : Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attach Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringeand saline supply line with spiked end.