Catalog Number

-

Brand Name

DRGEM

Version/Model Number

GXR-40

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

-

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

IZO

Product Code Name

Generator, High-Voltage, X-Ray, Diagnostic

Public Device Record Key

69b027e2-25bc-4c7b-8dc3-4ad9e8d5cb6a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-