CARDINAL HEALTH - SILVER EYE PACK - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: SILVER EYE PACK

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More Product Details

Catalog Number

SEY35EPSS2

Brand Name

CARDINAL HEALTH

Version/Model Number

SEY35EPSS2

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

57706f36-90a4-4528-8c77-e56c089fc655

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 14, 2022

Additional Identifiers

Package DI Number

50197106000357

Quantity per Package

6

Contains DI Package

10197106000359

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