Catalog Number

SPP99HD1AA

Brand Name

CARDINAL HEALTH

Version/Model Number

SPP99HD1AA

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

OJH

Product Code Name

Orthopedic tray

Public Device Record Key

b5fa91b3-7e5b-4124-acac-eb37d399718c

Public Version Date

May 24, 2022

Public Version Number

4

DI Record Publish Date

July 26, 2016

Package DI Number

50885425482953

Quantity per Package

3

Contains DI Package

10885425482955

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE