Catalog Number

8645442

Brand Name

DIRECTVIEW CR Gridded Cassette with PQ Screen

Version/Model Number

DIRECTVIEW CR Gridded Cassette with PQ Screen

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)

-

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

fcc00d4a-b347-43ff-bdc0-8fa1562fa42b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

60889978645442

Quantity per Package

5

Contains DI Package

40889978645448

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case