Catalog Number

766411150T

Brand Name

V-Mark™ Breast Biopsy Site Marker

Version/Model Number

11 ga

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"

-

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

K053518,K053518

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

807c0bfc-cb7e-4f7c-a431-fb89c1873572

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 23, 2015

Package DI Number

20886333007145

Quantity per Package

10

Contains DI Package

00886333007141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box