Catalog Number

1098912

Brand Name

Imaging Plate

Version/Model Number

Imaging Plate

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

EAM

Product Code Name

Screen, intensifying, radiographic

Public Device Record Key

e1a6a633-268f-4cd8-b910-e3e9664ae5e7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

60889971098917

Quantity per Package

20

Contains DI Package

40889971098913

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case