Catalog Number

8346132

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

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

P080018

Product Code

MUE

Product Code Name

Full field digital,system,x-ray,mammographic

Public Device Record Key

fbb10d04-6c91-4d30-ba5c-38fac6be448c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-