Catalog Number

-

Brand Name

Neurosign V4

Version/Model Number

4013-NN

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

e273aeae-a712-4943-89e6-40b41f4e1237

Public Version Date

September 20, 2021

Public Version Number

4

DI Record Publish Date

May 09, 2018

Package DI Number

08718375866146

Quantity per Package

10

Contains DI Package

08718375865088

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfbox