Catalog Number

SMUC13C

Brand Name

SenoMark® UltraCor® Breast Tissue Marker

Version/Model Number

SMUC13C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K123911,K123911

Product Code

NEU

Product Code Name

MARKER, RADIOGRAPHIC, IMPLANTABLE

Public Device Record Key

753f32ce-b917-4c00-84da-9c4deceea554

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 25, 2015

Package DI Number

10801741032346

Quantity per Package

5

Contains DI Package

00801741032349

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA