Catalog Number

-

Brand Name

NICO BrainPath

Version/Model Number

NN-8011

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GZT

Product Code Name

Retractor, Self-Retaining, For Neurosurgery

Public Device Record Key

e0f376bf-f13d-4606-8476-110f03f69980

Public Version Date

June 08, 2021

Public Version Number

3

DI Record Publish Date

September 14, 2016

Package DI Number

10816744028111

Quantity per Package

2

Contains DI Package

00816744028114

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-