Catalog Number

STAR1001

Brand Name

MammoStar™

Version/Model Number

STAR1001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

d06608c2-442c-432c-8474-b98f9794b6f7

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

10858015005353

Quantity per Package

10

Contains DI Package

00858015005356

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton