Catalog Number

-

Brand Name

GoldSelect™

Version/Model Number

DGE-60

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 19, 2018

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

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

990dab2c-13f1-465a-a32a-ec4537d8b328

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

October 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-