Catalog Number

1035740

Brand Name

CARESTREAM DRX-EVOLUTION

Version/Model Number

CARESTREAM DRX-EVOLUTION

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 10, 2018

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

-

Product Code

IZO

Product Code Name

Generator, high-voltage, x-ray, diagnostic

Public Device Record Key

a9b34ea0-42b2-496d-8ad1-6c8b2afc2298

Public Version Date

December 12, 2018

Public Version Number

3

DI Record Publish Date

December 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-