Catalog Number

SEY53VTCR1

Brand Name

CARDINAL HEALTH

Version/Model Number

SEY53VTCR1

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

645ccbe5-dd2c-4768-966e-a7198956c406

Public Version Date

January 29, 2021

Public Version Number

1

DI Record Publish Date

January 21, 2021

Package DI Number

50888439993033

Quantity per Package

6

Contains DI Package

10888439993035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE