Catalog Number

8602773

Brand Name

DRX-Evolution Plus System

Version/Model Number

DRX-Evolution Plus 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

Yes

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

K091889

Product Code

KPR

Product Code Name

System, x-ray, stationary

Public Device Record Key

629001e7-51cf-4da2-89b5-caa86cff9d0c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-