Catalog Number

-

Brand Name

Gold Marker

Version/Model Number

GM1052

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

K103449

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

86b823cb-c494-4edf-a68f-6bd0cba69696

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-