Catalog Number

-

Brand Name

Gold Maker

Version/Model Number

GM1054

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

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

f76c9ef0-01cf-418f-af66-e8f1264553b1

Public Version Date

August 13, 2018

Public Version Number

1

DI Record Publish Date

July 11, 2018

Package DI Number

30812444026291

Quantity per Package

10

Contains DI Package

00812444026290

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-