CARDINAL HEALTH - EYE PACK - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: EYE PACK

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More Product Details

Catalog Number

SEY21EYAG4

Brand Name

CARDINAL HEALTH

Version/Model Number

SEY21EYAG4

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"

Yes

For Single-Use

Yes

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

OJK

Product Code Name

Eye tray

Device Record Status

Public Device Record Key

10e6a5ec-21e2-4dd3-aea2-d7d275153365

Public Version Date

March 04, 2020

Public Version Number

1

DI Record Publish Date

February 25, 2020

Additional Identifiers

Package DI Number

50888439712559

Quantity per Package

4

Contains DI Package

10888439712551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40