Catalog Number

SEY56CPUV7

Brand Name

CARDINAL HEALTH

Version/Model Number

SEY56CPUV7

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

OJK

Product Code Name

Eye tray

Public Device Record Key

cfe6bdb1-1b6d-45eb-b18e-3af2429e23f3

Public Version Date

April 22, 2022

Public Version Number

1

DI Record Publish Date

April 14, 2022

Package DI Number

50195594643247

Quantity per Package

2

Contains DI Package

10195594643249

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE