Catalog Number

SMEC12GSS

Brand Name

SenoMark® Breast Tissue Marker

Version/Model Number

SMEC12GSS

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

K050090,K050090

Product Code

NEU

Product Code Name

MARKER, RADIOGRAPHIC, IMPLANTABLE

Public Device Record Key

b159d20a-f3fc-4fdf-8191-b8c04b73b442

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 01, 2015

Package DI Number

10801741031929

Quantity per Package

10

Contains DI Package

00801741031922

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA