Catalog Number

MP101

Brand Name

MammoPad Radiolucent Cushion

Version/Model Number

MP101

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062141,K062141

Product Code

IZH

Product Code Name

System, x-ray, mammographic

Public Device Record Key

f491de10-4604-4ca7-8b14-cd8dd13d297a

Public Version Date

March 11, 2019

Public Version Number

4

DI Record Publish Date

May 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-