Catalog Number

SEY13ESPMH

Brand Name

CARDINAL HEALTH

Version/Model Number

SEY13ESPMH

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

db64d3c0-f858-4b06-affb-edde3d2f363b

Public Version Date

January 14, 2020

Public Version Number

1

DI Record Publish Date

January 06, 2020

Package DI Number

50888439659823

Quantity per Package

3

Contains DI Package

10888439659825

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE