Catalog Number

-

Brand Name

Neurosign V4

Version/Model Number

5875-00

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

Yes

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

-

Product Code

ETN

Product Code Name

Stimulator, Nerve

Public Device Record Key

0e955620-877d-44e1-baf3-94a19cc3f356

Public Version Date

July 12, 2022

Public Version Number

1

DI Record Publish Date

July 04, 2022

Package DI Number

08718375869680

Quantity per Package

1

Contains DI Package

08718375866061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfbox