Catalog Number

BNL-2010

Brand Name

Breast Needle Locator

Version/Model Number

BNL-2010

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

-

Product Code

MIJ

Product Code Name

NEEDLE, TUMOR LOCALIZATION

Public Device Record Key

9270a8d3-dc2b-4719-a953-5ce88032b040

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

10813079020391

Quantity per Package

10

Contains DI Package

00813079020394

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton