Catalog Number

BLN2005

Brand Name

Breast Localization Needles

Version/Model Number

BLN2005

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

3348cd24-d17b-400d-981e-36805d8af9a2

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Package DI Number

20886333007503

Quantity per Package

10

Contains DI Package

00886333007509

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box