Catalog Number

NWA1US1N

Brand Name

NEUWAVE

Version/Model Number

NWA1US1N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 26, 2021

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

JAK

Product Code Name

System, x-ray, tomography, computed

Public Device Record Key

ec1f8779-d0ed-4d57-95bf-3cecb91c230f

Public Version Date

May 27, 2021

Public Version Number

3

DI Record Publish Date

November 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-