Catalog Number

-

Brand Name

FN NEEDLES

Version/Model Number

FN18-53T

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

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Public Device Record Key

6b05aa0a-47bc-44ee-8df2-d687edc8c8e7

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 06, 2017

Package DI Number

20790986006878

Quantity per Package

10

Contains DI Package

10790986007038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-