Catalog Number

ORC335552C

Brand Name

CARDINAL HEALTH

Version/Model Number

ORC335552C

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

LRP

Product Code Name

TRAY, SURGICAL

Public Device Record Key

7fb44315-2c08-42f1-bab1-04ca984eab15

Public Version Date

October 04, 2022

Public Version Number

1

DI Record Publish Date

September 26, 2022

Package DI Number

50195594798701

Quantity per Package

25

Contains DI Package

10195594798703

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE