Mara Water Vapor Probe Kit

Basic Information

• Brand Name: Mara Water Vapor Probe Kit
• Primary DI: 00857379006030
• Version / Model: DDK-16-050
• Catalog Number: DDK-16-050
• Company Name: AEGEA MEDICAL INC.
• Labeler DUNS: 825284834
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-16
• Public Version: 3
• Public Version Date: 2020-07-30
• Public Version Status: Update
• Public Device Record Key: ce9ab100-8adc-4535-8553-f82edece84c9

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNB	Device, Thermal Ablation, Endometrial	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
64809	Water vapour endometrial-ablation applicator	A hand-held device designed to apply water vapour for the ablation of the interior lining of the uterus (endometrium) to treat dysfunctional uterine bleeding (menorrhagia). It includes a proximal handle attached to distal components consisting of an outflow tube, pressure sensors, and a shaft with balloons to control vapour application. It is used with a dedicated control unit (not included) which supplies energy for heating saline in the handle to create vapour. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857379006030	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P160047	006