CS 7400 - CS 7400 SUB-SYSTEM - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: CS 7400 SUB-SYSTEM

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More Product Details

Catalog Number

8470411

Brand Name

CS 7400

Version/Model Number

CS 7400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

MUH

Product Code Name

System,x-ray,extraoral source,digital

Device Record Status

Public Device Record Key

506d2178-051b-45da-9f1f-9c8907e440ac

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARESTREAM HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 688