Catalog Number

-

Brand Name

GOLD MARKER NEEDLE

Version/Model Number

GM0852-SS15-1820

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K103449,K103449,K103449,K103449

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Public Device Record Key

5cdeddef-4477-45d2-8d95-d158c81fe0c2

Public Version Date

July 11, 2018

Public Version Number

4

DI Record Publish Date

November 02, 2017

Package DI Number

20812444027093

Quantity per Package

9

Contains DI Package

00812444027099

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-