Catalog Number

8637688

Brand Name

DIRECTVIEW CR Gridded Cassette with PQ Screen

Version/Model Number

DIRECTVIEW CR Gridded Cassette with PQ Screen

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 23, 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IXJ

Product Code Name

Grid, radiographic

Public Device Record Key

330302d6-3847-4b3c-abc0-4f3d998ff142

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

60889978637683

Quantity per Package

2

Contains DI Package

40889978637689

Package Discontinue Date

October 23, 2017

Package Status

Not in Commercial Distribution

Package Type

Case