FDA.reportPublic FDA data

Myriad-LX

Primary DI
00816744027230
Brand
Myriad-LX
Company
NICO CORPORATION
Model
NN-7023
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FTDLamp, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191599000NICO Myriad NOVUSNico Corporation2019-09-13GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816744027230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816744027230008167440272308167440272300816744027230

GMDN Terms#

Term, Definition table
TermDefinition
Electrical mains power cableAn insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
829838288
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816744021313NICO MyriadNN-13102025-07-30
00816744020118NICO MyriadNN-11102025-07-30
00816744021139NICO MyriadNN-11132025-07-30
00816744021337NICO MyriadNN-13132025-07-30
00816744024031NICO MyriadNN-40032025-07-30
00816744024048NICO MyriadNN-40042025-07-30
00816744024062NICO MyriadNN-40062025-07-30
00816744024079NICO MyriadNN-40072025-07-30
00816744024178NICO MyriadNN-40172025-07-30
00816744024185NICO MyriadNN-40182025-07-30
00816744027131NICO Myriad-LXNN-70132019-09-30
00816744020095NICO MyriadNN-10012024-11-13
00816744020101NICO MyriadNN-10002024-11-13
00816744027728NICO Myriad SPECTRANN-70722024-06-07
00816744027704NICO Myriad NOVUSNN-70702023-04-28
00816744028244NICO BrainPathNN-80242016-09-14
00816744028251NICO BrainPathNN-80252016-09-14
00816744028268NICO BrainPathNN-80262016-09-14
00816744028312NICO BrainPathNN-80312017-11-08
00816744028329NICO BrainPathNN-80322017-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194665008857A-decA-DEC, INC.FTD2026-05-07
10850009233032BihlerMedBihlerMed, L.L.C.FTD2026-01-12
04048675754947PolarisDrägerwerk AG & Co. KGaAFTD2025-11-05
03700712434526Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712435851Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436063Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436087Maquet PowerLED IIMAQUET SASFTD2025-09-03
00850036790020AliteRevelle Aesthetics, Inc.FTD2025-09-01
00860013851576Nova 3QED, INC.FTD2025-05-22
00860013851507BeamerQED, INC.FTD2025-05-21
00860013851514Nova 300QED, INC.FTD2025-05-21
08800053093767S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093774S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093781S300 Series DENTIS CO. ,LTDFTD2025-02-19
08800053093798S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093804S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093828S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093835S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093842S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093859S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093866S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093873S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093880S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093897S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093903S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093910S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093927S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093941S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093958S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093972S300 SeriesDENTIS CO. ,LTDFTD2025-02-19