Catalog Number

-

Brand Name

Breast localisation needle

Version/Model Number

BLM-1120-20-0125

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

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Public Device Record Key

ea6cce82-6297-4357-8a25-30276dce85e6

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 17, 2018

Package DI Number

04260277173029

Quantity per Package

10

Contains DI Package

04260277172978

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-