Catalog Number

-

Brand Name

Natus

Version/Model Number

071-422900

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"

Yes

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

K120979

Product Code

GWF

Product Code Name

Stimulator, Electrical, Evoked Response

Public Device Record Key

2bc3570b-1dfd-4175-98c7-b8e168f7e5f4

Public Version Date

November 05, 2021

Public Version Number

1

DI Record Publish Date

October 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-