Catalog Number

-

Brand Name

Golden Eagle

Version/Model Number

GR595

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K012258

Product Code

INI

Product Code Name

Vehicle, Motorized 3-Wheeled

Public Device Record Key

8de80e42-e28c-46f9-9ac1-234e70751378

Public Version Date

March 15, 2022

Public Version Number

1

DI Record Publish Date

March 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-