Catalog Number

-

Brand Name

Selenia FFDM

Version/Model Number

4-000-0293

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P010025

Product Code

MUE

Product Code Name

Full field digital,system,x-ray,mammographic

Public Device Record Key

829ea679-e5e9-4497-810f-d65ab8d1db4a

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-