Catalog Number

AG4322

Brand Name

DRX 2530C Detector

Version/Model Number

DRX 2530C Detector

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2021

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

MQB

Product Code Name

Solid state x-ray imager (flat panel/digital imager)

Public Device Record Key

86feca94-f042-4ce9-b430-4035abdee39f

Public Version Date

October 04, 2021

Public Version Number

3

DI Record Publish Date

February 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-