Catalog Number

750-020021-00

Brand Name

NeuroOmega Drive Headstage Kit

Version/Model Number

NeuroOmega Drive Headstage Kit

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

K171581

Product Code

GZL

Product Code Name

Electrode, Depth

Public Device Record Key

b9af2e30-ad8a-4d5e-8ff6-3452c288aa3b

Public Version Date

November 22, 2019

Public Version Number

3

DI Record Publish Date

August 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-