Catalog Number

4484

Brand Name

NeuroPort Inserter Assembly

Version/Model Number

4484

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

-

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

K070272

Product Code

GZL

Product Code Name

Electrode, Depth

Public Device Record Key

cf4ac80b-6636-4d7d-95f3-40a020e91332

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-