Catalog Number

8304891

Brand Name

Imaging Plate

Version/Model Number

Imaging Plate

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 17, 2017

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

bd4e4f4e-e00a-4250-a6b0-5324c2b1cb33

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-