FDA.reportPublic FDA data

Aegea-Medical-Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146124383014612438AEGEA MEDICAL INCORPORATION1N2020-04-254055A Campbell Avenue Menlo Park CA US 94025

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00857379006023Mara Console - 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.6507011125tkelly@aegeamedical.com
00857379006030Mara Water Vapor Probe Kit - Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringeand saline supply line with spiked end.6507011125tkelly@aegeamedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2250311888107492P160047MARA™ Vapor System, MARA™ Vapor Probe Procedure Kit, MARA™ Vapor Generator and MARA™ Vapor Generator Accessory KitMNB2017-06-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MNB12017-06-14

GUDID#