Catalog Number

SBAHDDUN11

Brand Name

CARDINAL HEALTH

Version/Model Number

SBAHDDUN11

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

LRO

Product Code Name

General surgery tray

Public Device Record Key

f3d9810c-1750-4478-92d1-35d440858f22

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

50197106004676

Quantity per Package

2

Contains DI Package

10197106004678

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE