Catalog Number

-

Brand Name

HydroMARK Breast Biopsy Site Marker

Version/Model Number

4010-02-15-T3

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

K121113,K121113

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

93f9753e-d74f-4f10-9350-3c9d98c3c746

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 25, 2020

Package DI Number

10841911102158

Quantity per Package

10

Contains DI Package

00841911102151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-