Catalog Number

STMKMT11GSS

Brand Name

StarchMark® Breast Tissue Marker

Version/Model Number

STMKMT11GSS

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"

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

K131654,K131654

Product Code

NEU

Product Code Name

MARKER, RADIOGRAPHIC, IMPLANTABLE

Public Device Record Key

a2758072-cda4-44b1-ad53-5b077b4a6b2b

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 02, 2015

Package DI Number

10801741032186

Quantity per Package

10

Contains DI Package

00801741032189

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA