Mara Water Vapor Probe Kit DDK-16-050

GUDID 00857379006030

Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringe and saline supply line with spiked end.

AEGEA MEDICAL INC.

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Primary Device ID00857379006030
NIH Device Record Keyce9ab100-8adc-4535-8553-f82edece84c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMara Water Vapor Probe Kit
Version Model NumberDDK-16-050
Catalog NumberDDK-16-050
Company DUNS825284834
Company NameAEGEA MEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com
Phone6507011125
Emailtkelly@aegeamedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857379006030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNBDevice, Thermal Ablation, Endometrial

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-24
Device Publish Date2020-03-16

Devices Manufactured by AEGEA MEDICAL INC.

00857379006023 - Mara Console2020-03-24 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 Kit2020-03-24Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringe and saline supply line with spiked end.
00857379006030 - Mara Water Vapor Probe Kit2020-03-24 Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringe and saline s

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