Catalog Number

ASY-11738

Brand Name

Selenia Dimensions

Version/Model Number

ASY-11738

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

a37b2dc6-250b-4ac1-ada1-63e8056ccdcc

Public Version Date

November 26, 2019

Public Version Number

1

DI Record Publish Date

November 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-