Catalog Number

-

Brand Name

NICO BrainPath

Version/Model Number

NN-8045

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

K172433,K172433

Product Code

GZT

Product Code Name

Retractor, Self-Retaining, For Neurosurgery

Public Device Record Key

2e1a193b-5c91-4523-8c93-7c2c36ef8fa3

Public Version Date

December 09, 2021

Public Version Number

3

DI Record Publish Date

April 15, 2020

Package DI Number

10816744038455

Quantity per Package

2

Contains DI Package

00816744028459

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-