Catalog Number

SEY11MNCHZ

Brand Name

CARDINAL HEALTH

Version/Model Number

SEY11MNCHZ

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

233a0b75-f8d7-4c31-bdb9-c6f81fa8a59b

Public Version Date

April 13, 2021

Public Version Number

1

DI Record Publish Date

April 05, 2021

Package DI Number

50195594949844

Quantity per Package

5

Contains DI Package

10195594949846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE