Catalog Number

750-000025-00

Brand Name

NeuroOmega Autoclavable

Version/Model Number

Drive-Head Stage

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

K123796

Product Code

GZL

Product Code Name

Electrode, Depth

Public Device Record Key

0a96163f-2c1e-45a6-9bb9-bbf2ee2e828f

Public Version Date

November 22, 2019

Public Version Number

4

DI Record Publish Date

October 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-