FDA.reportPublic FDA data

NICO Myriad SPECTRA

Primary DI
00816744027483
Brand
NICO Myriad SPECTRA
Company
NICO CORPORATION
Model
NN-7048
Device description
Myriad SPECTRA Foot Pedal
Published
2024-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QFXDiagnostic Neurosurgical Microscope Filter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFXDiagnostic Neurosurgical Microscope FilterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232567000Myriad SPECTRA Light SourceNico Corporation2024-03-14QFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816744027483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816744027483008167440274838167440274830816744027483

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

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
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
07630802403414FL400 for M530Leica Microsystems (Schweiz) AGQFX2025-10-09
04049539070159BLUE 400Carl Zeiss Meditec AGQFX2024-10-07
04049539070593BLUE 400 SCarl Zeiss Meditec AGQFX2024-10-07
00816744027728NICO Myriad SPECTRANICO CORPORATIONQFX2024-06-07
00816744027537NICO Myriad SPECTRANICO CORPORATIONQFX2024-04-01