Catalog Number

-

Brand Name

Natus

Version/Model Number

019-475800

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

GXZ

Product Code Name

Electrode, Needle

Public Device Record Key

80c8b268-0a85-48d0-ae3f-d7dfb8a7a6d8

Public Version Date

April 09, 2021

Public Version Number

1

DI Record Publish Date

April 01, 2021

Package DI Number

08718375867136

Quantity per Package

24

Contains DI Package

08718375867143

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf box