Catalog Number

700-006010-00

Brand Name

NeuroNav Drive

Version/Model Number

NeuroNav Drive

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K071697

Product Code

GZL

Product Code Name

Electrode, Depth

Public Device Record Key

0608e7d6-4964-47e6-8bc4-6553ed500542

Public Version Date

November 22, 2019

Public Version Number

5

DI Record Publish Date

February 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-