Catalog Number

NOW-NFF000-00

Brand Name

Neuro Omega with NeuroFortis drive + 2 basic stimulation Slots

Version/Model Number

Neuro Omega with NeuroFortis drive + 2 basic stimulation Slots

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

K171581

Product Code

-

Product Code Name

-

Public Device Record Key

fe687add-07be-449f-82dd-9e27692fcbe9

Public Version Date

May 12, 2020

Public Version Number

1

DI Record Publish Date

May 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-