FDA.reportPublic FDA data

NICO Myriad SPECTRA

Primary DI
00816744027728
Brand
NICO Myriad SPECTRA
Company
NICO CORPORATION
Model
NN-7072
Device description
Kit - US
Published
2024-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
FSTLight, Surgical, Fiberoptic
GEIElectrosurgical, Cutting & Coagulation & Accessories
HBCMotor, Drill, Electric
HBIIlluminator, Fiberoptic, Surgical Field
QFXDiagnostic Neurosurgical Microscope Filter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery2
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
HBCMotor, Drill, ElectricNeurology2
HBIIlluminator, Fiberoptic, Surgical FieldGeneral, Plastic Surgery2
QFXDiagnostic Neurosurgical Microscope FilterNeurology2

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
00816744027728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816744027728008167440277288167440277280816744027728

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816744028459NICO BrainPathNN-80452020-04-15
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
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
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10381780544197TruDi®ACCLARENT, INC.ERL2026-11-03
10381780544210TruDi®ACCLARENT, INC.ERL2026-11-03
10381780544234TruDi®ACCLARENT, INC.ERL2026-11-03
10381780544258TruDi®ACCLARENT, INC.ERL2026-11-03
10381780544272TruDi®ACCLARENT, INC.ERL2026-11-03
B382SD89259100Surgical DirectSurgical Direct, Inc.GEI2026-11-03
B382SD89519020Surgical DirectSurgical Direct, Inc.GEI2026-11-03
SD89839030Surgical DirectSurgical Direct, Inc.GEI2026-11-03
03830066950271GREEN IRFIskra Medical, d.o.o.GEI2026-11-02
00199150071999MedtronicMEDTRONIC NAVIGATION, INC.GEI2026-11-01
00810026184093Bipolar ForcepsSONIQUENCE, LLCGEI2026-11-01
00841019124147KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-31
04953170467875THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-29
04953170467882THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-29
00841019124178KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-28
00841019124161KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-27
00841019124239KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-27
00190776439774MilleniumAvalign Technologies, Inc.GEI2026-10-26
10884521783829LigaSureCovidien LPGEI2026-10-23
00190776436858MillenniumAvalign Technologies, Inc.GEI2026-10-22
B382SD77105560Surgical DirectSurgical Direct, Inc.GEI2026-10-22
00190776435752MillenniumAvalign Technologies, Inc.GEI2026-10-21
00190776435769MillenniumAvalign Technologies, Inc.GEI2026-10-21
00841019124192KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-21
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19