Medical X-ray Cassette with Green 400 Screens - 35X43CM MX CASS W/GRN 400 SCREEN - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: 35X43CM MX CASS W/GRN 400 SCREEN

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More Product Details

Catalog Number

6807077

Brand Name

Medical X-ray Cassette with Green 400 Screens

Version/Model Number

Medical X-ray Cassette with Green 400 Screens

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K896708,K896708

Product Code Details

Product Code

IXA

Product Code Name

Cassette, radiographic film

Device Record Status

Public Device Record Key

f8aa0e2a-06f9-481f-8857-1bfd473e30e0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

60889976807071

Quantity per Package

5

Contains DI Package

40889976807077

Package Discontinue Date

-

Package Status

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