Catalog Number

-

Brand Name

GOLD MARKER NEEDLE

Version/Model Number

GM0833-1820

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)

-

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

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

60964a22-7b9b-4d97-9979-044229cb72ad

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

October 24, 2015

Package DI Number

30812444022231

Quantity per Package

9

Contains DI Package

00812444022230

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-