AccessGUDID - DEVICE: Mara Water Vapor Probe Kit (00857379006030)

GUDID

Device Identifier (DI) Information

Brand Name: Mara Water Vapor Probe Kit
Version or Model: DDK-16-050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DDK-16-050
Company Name: AEGEA MEDICAL INC.

Primary DI Number: 00857379006030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825284834 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNB	Device, Thermal Ablation, Endometrial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160047	006

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ce9ab100-8adc-4535-8553-f82edece84c9
Public Version Date: July 30, 2020
Public Version Number: 3
DI Record Publish Date: March 16, 2020