Catalog Number

1290386

Brand Name

DIRECTVIEW CR Mammography Cassette with EHR-M Screen

Version/Model Number

DIRECTVIEW CR Mammography Cassette with EHR-M Screen

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 11, 2021

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

P080018,P080018

Product Code

MUE

Product Code Name

Full field digital,system,x-ray,mammographic

Public Device Record Key

f295b42c-cc8d-436a-b365-bd252d04651f

Public Version Date

May 14, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

60889971290380

Quantity per Package

5

Contains DI Package

40889971290386

Package Discontinue Date

May 11, 2021

Package Status

Not in Commercial Distribution

Package Type

Case