Mara Console

GUDID 00888937026870

Mara Console- Endometrial Ablation

Coopersurgical, Inc.

Water vapour endometrial-ablation control unit
Primary Device ID00888937026870
NIH Device Record Keybbf8bd79-0dd9-4c5a-9112-3f73dde93e8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMara Console
Version Model NumberGEN-16-050
Company DUNS801895244
Company NameCoopersurgical, 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937026870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNBDevice, Thermal Ablation, Endometrial

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-21
Device Publish Date2024-03-13

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