Catalog Number

SMA35HSMO2

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA35HSMO2

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

30943b1f-db18-4465-8e0c-5e313e68d77e

Public Version Date

January 05, 2022

Public Version Number

1

DI Record Publish Date

December 28, 2021

Package DI Number

50195594485274

Quantity per Package

4

Contains DI Package

10195594485276

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE