Catalog Number

5590000-20

Brand Name

Revolution

Version/Model Number

Apex

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191777

Product Code

JAK

Product Code Name

System, x-ray, tomography, computed

Public Device Record Key

7e267c64-bcc4-4be0-8635-f80937718d9f

Public Version Date

May 02, 2022

Public Version Number

2

DI Record Publish Date

November 27, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-