Catalog Number

-

Brand Name

MammoPad Radiolucent Cushion

Version/Model Number

MP301-10

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

f8c1b084-4122-45d2-8f87-991fb4a34045

Public Version Date

March 11, 2019

Public Version Number

4

DI Record Publish Date

July 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-