FDA.reportPublic FDA data

Mara Console

Primary DI
00888937026870
Brand
Mara Console
Company
Coopersurgical, Inc.
Model
GEN-16-050
Device description
Mara Console- Endometrial Ablation
Published
2024-03-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MNBDevice, Thermal Ablation, Endometrial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNBDevice, Thermal Ablation, EndometrialUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160047000MARA™ Vapor System, MARA™ Vapor Probe Procedure Kit, MARA™ Vapor Generator and MARA™ Vapor Generator Accessory KitCooperSurgical, Inc.2017-06-14MNB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937026870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937026870008889370268708889370268700888937026870

GMDN Terms#

Term, Definition table
TermDefinition
Water vapour endometrial-ablation control unitAn electrically-powered device designed to regulate the pressure and temperature of water for its vaporization and subsequent application, via an attached applicator (not included), to ablate the interior lining of the uterus (endometrium) to treat dysfunctional uterine bleeding (menorrhagia). It is typically a unit consisting of a digital user-interface [e.g., liquid-crystal display (LCD)] and treatment setting controls.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11
05060488047039EZ-Tip600µm7-72-2600/12025-04-11
05060488047046EZ-Tip75µm7-72-2075/52025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937026887Mara Coopersurgical, Inc.MNB2023-12-01
00850044503018MinitouchMicrocube, LLCMNB2023-10-18
00850044503117MinitouchMicrocube, LLCMNB2023-10-18
00850044503124MinitouchMicrocube, LLCMNB2023-10-18
00850044503131MinitouchMicrocube, LLCMNB2023-10-18
00850044503148MinitouchMicrocube, LLCMNB2023-10-18
00850044503155MinitouchMicrocube, LLCMNB2023-10-18
00850044503162MinitouchMicrocube, LLCMNB2023-10-18
00850044503209MinitouchMicrocube, LLCMNB2023-10-18
10850044503015MinitouchMicrocube, LLCMNB2023-10-18
15420045515154NovaSureHologic, Inc.MNB2023-04-22
00850008595042Exhaust Collection BagCHANNEL MEDSYSTEMS, INC.MNB2023-04-06
00850033976014Genesys HTA Control UnitMinerva Surgical, Inc.MNB2022-06-08
00850033976021Genesys HTA Control Unit - RefurbishedMinerva Surgical, Inc.MNB2022-06-08
00850033976038Genesys HTA ProCervaMinerva Surgical, Inc.MNB2022-06-08
15420045514294NovaSureHologic, Inc.MNB2021-07-02
15420045514300NovaSureHologic, Inc.MNB2021-07-02
25420045514307NovaSureHologic, Inc.MNB2021-07-02
00850008595028Exhaust Collection BagCHANNEL MEDSYSTEMS, INC.MNB2020-08-21
20850008595022Exhaust Collection BagCHANNEL MEDSYSTEMS, INC.MNB2020-08-21
00850008595035Cerene Cryotherapy DeviceCHANNEL MEDSYSTEMS, INC.MNB2020-08-21
00857379006023Mara ConsoleAEGEA MEDICAL INC.MNB2020-03-16
00857379006030Mara Water Vapor Probe KitAEGEA MEDICAL INC.MNB2020-03-16
00862393000100Minerva RF ControllerMinerva Surgical, Inc.MNB2017-06-27
00862393000117Minerva Disposable HandpiecesMinerva Surgical, Inc.MNB2017-06-27
00862393000131Minerva Argon Gas Canister (5 pack)Minerva Surgical, Inc.MNB2017-06-27
00862393000148Minerva Co2 CanistersMinerva Surgical, Inc.MNB2017-06-27
00862393000155Minerva DesiccantMinerva Surgical, Inc.MNB2017-06-27
00862393000162Minerva Single Sterile Disposable HandpieceMinerva Surgical, Inc.MNB2017-06-27
00862393000179Minerva Hegar Dilator (3 Pack)Minerva Surgical, Inc.MNB2017-06-27