FDA.reportPublic FDA data

NICO BrainPath

Primary DI
10816744028111
Brand
NICO BrainPath
Company
NICO CORPORATION
Model
NN-8011
Device description
Sheath 13.5 mm x 50 mm
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZTRetractor, Self-Retaining, For Neurosurgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816744028111PackageGS12In Commercial Distribution
00816744028114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081674402811110816744028111
00816744028114008167440281148167440281140816744028114

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical retraction cannulaA sterile single-lumen surgical device designed to be used with an obturator to atraumatically displace brain tissues without tissue penetration (e.g., careful insertion between gyri) to create a surgical access corridor to a specific lesion/abnormality within the brain. It is made of polymer materials and typically includes depth markings. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
829838288
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10381780537533Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537571Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537588Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537625TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537649TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537663TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537670TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537694TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537717TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537724TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537748TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537779Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537816TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537854TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537861TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537878Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537885Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537908MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537915MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537960MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537977MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780538004MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780538042BUDDE®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780538066BUDDE®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780344605Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344612Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344629Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344636Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344643Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344650Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23