Catalog Number

-

Brand Name

Affirm Prone Biopsy System

Version/Model Number

System Software

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

K153486

Product Code

IZH

Product Code Name

System, x-ray, mammographic

Public Device Record Key

b85857fd-54a3-466f-834f-ea846fa73244

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-