Catalog Number

NT901212

Brand Name

Natus®

Version/Model Number

NT901212

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

-

Product Code

PIY

Product Code Name

Stainless Steel Instrument, Shunt System Implantation

Public Device Record Key

79b61e64-1564-4c8f-b1d3-dc140c7b7e09

Public Version Date

April 13, 2020

Public Version Number

1

DI Record Publish Date

April 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-