FDA.reportPublic FDA data

Minitouch

Primary DI
00850044503124
Brand
Minitouch
Company
Microcube, LLC
Model
4003
Device description
Display
Published
2023-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
P230002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230002000Minitouch 3.8 Era System (Minitouch System)Microcube, LLC2023-07-28MNB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850044503124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044503124008500445031248500445031240850044503124

GMDN Terms#

Term, Definition table
TermDefinition
Microwave ablation systemAn assembly of devices intended to generate and administer microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. It consists of an electrically-powered microwave energy generator, a user interface, and controls; a microwave ablation probe (not included) is used for energy application to the target area. It is intended to be used in percutaneous, laparoscopic, natural orifice or open surgery procedures to ablate tissue typically in the liver, lung, pancreas, kidney, and uterus (e.g., endometrial ablation).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
615286320
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044503018MinitouchHandpiece 3.8 Era45012023-10-18
00850044503117Minitouch40022023-10-18
00850044503131Minitouch40042023-10-18
00850044503148Minitouch40052023-10-18
00850044503155Minitouch40062023-10-18
00850044503162Minitouch40102023-10-18
00850044503209Minitouch4001-012023-10-18
10850044503015MinitouchHandpiece 3.8 Era45012023-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937026870Mara ConsoleCoopersurgical, Inc.MNB2024-03-13
00888937026887Mara Coopersurgical, Inc.MNB2023-12-01
00850044503018MinitouchMicrocube, LLCMNB2023-10-18
00850044503117MinitouchMicrocube, 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