Catalog Number

5PCT2

Brand Name

CR HD5.0 AEC CASSETTE

Version/Model Number

CR HD5.0 AEC CASSETTE 18X24

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

K111324

Product Code

MUE

Product Code Name

Full field digital,system,x-ray,mammographic

Public Device Record Key

5784d0e2-ec46-4035-bd6e-4ffbd4d4ebb4

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

-