Catalog Number

5942537

Brand Name

CS 7600 Smart Plate

Version/Model Number

CS 7600 Smart 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

4304add7-0b6a-4c1b-acd4-691af76fcda6

Public Version Date

February 25, 2020

Public Version Number

1

DI Record Publish Date

February 17, 2020

Package DI Number

60192155942532

Quantity per Package

20

Contains DI Package

40192155942538

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS