Catalog Number

SPP99EY2AA

Brand Name

CARDINAL HEALTH

Version/Model Number

SPP99EY2AA

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

5f77b6b3-1b7c-463b-a3b1-68e133ce3aab

Public Version Date

May 24, 2022

Public Version Number

5

DI Record Publish Date

January 06, 2017

Package DI Number

50885425973666

Quantity per Package

8

Contains DI Package

10885425973668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE