CS 7600 Smart Plate - CS 7600 SMART PLATE SIZE 0 - 4 PCS - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: CS 7600 SMART PLATE SIZE 0 - 4 PCS

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More Product Details

Catalog Number

1014422

Brand Name

CS 7600 Smart Plate

Version/Model Number

CS 7600 Smart Plate

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 05, 2017

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

EAM

Product Code Name

Screen, intensifying, radiographic

Device Record Status

Public Device Record Key

3662176f-fdd3-4f5d-9c0d-4e071d079a0f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

60889971014429

Quantity per Package

20

Contains DI Package

40889971014425

Package Discontinue Date

January 03, 2017

Package Status

Not in Commercial Distribution

Package Type

Case

"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