FDA.reportPublic FDA data

NICO Myriad-LX

Primary DI
00816744027643
Brand
NICO Myriad-LX
Company
NICO CORPORATION
Model
NN-7064
Device description
Light Source - Analog
Published
2023-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSSLight, Surgical, Floor Standing
FTDLamp, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSSLight, Surgical, Floor StandingGeneral, Plastic Surgery2
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
00816744027643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816744027643008167440276438167440276430816744027643

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose light sourceA mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
317-660-7118info@NICOneuro.com

Regulatory Flags#

DUNS number
829838288
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816744021313NICO MyriadNN-13102025-07-30
00816744027230Myriad-LXNN-70232025-08-11
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

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
10686864056819Medicom SafeMaskAMD Medicom IncFSS2025-01-23
00850036790013AveliRevelle Aesthetics, Inc.FTD2024-02-26
B773KLEDL0KLYOKLYO MEDICAL SYSTEMS INC.FTD2024-02-22
B773KLEDS0KLYOKLYO MEDICAL SYSTEMS INC.FTD2024-02-22
14026704741837PILLINGTELEFLEX INCORPORATEDFSS2024-01-16
03700712432423Maquet EzeaMAQUET SASFTD2024-01-10
03700712432430Maquet EzeaMAQUET SASFTD2024-01-10
03700712432461Maquet EzeaMAQUET SASFTD2024-01-10
03700712432478Maquet EzeaMAQUET SASFTD2024-01-10
03700712432737Maquet EzeaMAQUET SASFTD2024-01-10
03700712432928Maquet EzeaMAQUET SASFTD2024-01-10
00887761967250Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFTD2023-07-11
03700712430597Maquet PowerLED IIMAQUET SASFTD2023-07-05
00887761967274Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFTD2023-06-26
M678TLCSLS0TracLuxSUNOPTIC TECHNOLOGIES LLCFTD2023-05-29
08881300212001KLARO In Vivo Surgical LightingVIVO SURGICAL PRIVATE LIMITEDFTD2023-03-13
M678SLSS0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerSUNOPTIC TECHNOLOGIES LLCFTD2023-03-01
00887761968493VidiaPortBaxter Medical Systems GmbH + Co. KGFTD2023-01-17
00887761968325iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2023-01-05
00887761968295iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2023-01-05
00887761968394TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2023-01-05
00887761968448TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2023-01-05
00887761968387TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2023-01-04
00887761968127Pre-Install SetBaxter Medical Systems GmbH + Co. KGFTD2022-12-15
00887761968271iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2022-12-15
00887761968301iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2022-12-15