Catalog Number

AC-UPGRADE

Brand Name

NEUWAVE

Version/Model Number

AC-UPGRADE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 17, 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

K192427

Product Code

JAK

Product Code Name

System, x-ray, tomography, computed

Public Device Record Key

d1df0ac5-0f7e-4eee-b740-841568ab55ee

Public Version Date

May 18, 2021

Public Version Number

2

DI Record Publish Date

May 06, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-