Catalog Number

-

Brand Name

Pristina Serena

Version/Model Number

KAS2

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

K173576

Product Code

MUE

Product Code Name

Full field digital, system, x-ray, mammographic

Public Device Record Key

6375225d-1ea6-4da4-b2ce-dd850ce6731d

Public Version Date

October 25, 2022

Public Version Number

2

DI Record Publish Date

April 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-