Catalog Number

5R7U4

Brand Name

CR MD4.0R GENERAL CASSETTE

Version/Model Number

CR MD4.0R GENERAL CASSETTE 24X30

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

K141602

Product Code

MQB

Product Code Name

Solid state x-ray imager (flat panel/digital imager)

Public Device Record Key

ed849767-adef-434f-8d14-fcb59c79a4df

Public Version Date

June 14, 2019

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-