Catalog Number

AF5684

Brand Name

DRX-Revolution Mobile X-ray System

Version/Model Number

DRX-Revolution Mobile X-ray System

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IZO

Product Code Name

Generator, high-voltage, x-ray, diagnostic

Public Device Record Key

da081f1f-ecbf-4d3f-b83e-a0abce7faf82

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-