Catalog Number

-

Brand Name

Planmed

Version/Model Number

Clarity

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

-

Product Code

MUE

Product Code Name

Full Field Digital, System, X-Ray, Mammographic

Public Device Record Key

e211c23c-04bd-4923-af74-9dcaf6b42143

Public Version Date

April 20, 2021

Public Version Number

2

DI Record Publish Date

November 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-