Catalog Number

BLN2103

Brand Name

Breast Localization Needles

Version/Model Number

BLN2103

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

bd866b34-c1fb-438d-aaf3-1f90b7d18e24

Public Version Date

July 07, 2022

Public Version Number

1

DI Record Publish Date

June 29, 2022

Package DI Number

20886333007466

Quantity per Package

10

Contains DI Package

00886333007462

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box