Catalog Number

8981318

Brand Name

Elite CR System

Version/Model Number

Elite CR System

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 12, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K020635

Product Code

MQB

Product Code Name

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

Public Device Record Key

32db3b86-40c1-46d2-89ca-ea40faba7a1c

Public Version Date

March 09, 2020

Public Version Number

9

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-