Mara

Basic Information

• Brand Name: Mara
• Primary DI: 00888937026887
• Version / Model: DDK-16-050
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-01
• Public Version: 3
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: a9c47fbf-1952-4f84-9f98-09c40ddee402

Device Description

Mara Water Vapor Probe Kit

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: No
• 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	00888937026887	GS1
Previous	00857379006030	GS1

Premarket Submissions

Submission Number	Supplement Number
P160047	000