FDA.reportPublic FDA data

NICO BrainPath

Primary DI
00816744029050
Brand
NICO BrainPath
Company
NICO CORPORATION
Model
NN-9005
Device description
Manipulation Tool
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZTRetractor, Self-Retaining, For Neurosurgery
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816744029050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816744029050008167440290508167440290500816744029050

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical retraction cannula manipulation toolA hand-held, manual surgical device intended to be used to manipulate the position of a neurosurgical retraction cannula during brain surgery. It is typically made of metal, has a handle at the proximal end and a distal portion (e.g., hook-like) intended to attach to the cannula. It is not intended to manipulate tissues directly. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization""]"
Hydrogen Peroxide;Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
829838288
Device count
1
Serial number
true
Sterilization required before use
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
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

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Primary DI, Brand, Company table
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B382SD9176201020Surgical DirectSurgical Direct, Inc.MDM2026-07-13
03661219436348LANDANGERLANDANGERMDM2026-07-12
00810158210615PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
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