Catalog Number

CA8400

Brand Name

CARDINAL HEALTH

Version/Model Number

CA8400

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LRP

Product Code Name

TRAY, SURGICAL

Public Device Record Key

3b43b4c7-ae20-4fa8-81e2-5eac4021885e

Public Version Date

April 22, 2019

Public Version Number

1

DI Record Publish Date

April 12, 2019

Package DI Number

50885380133600

Quantity per Package

4

Contains DI Package

10885380133602

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE