Catalog Number

SMA33GLOU9

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA33GLOU9

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

OHD

Product Code Name

Gynecological laparoscopic kit

Public Device Record Key

3e1772c8-bb6b-4baf-9880-7d9089c265ad

Public Version Date

October 27, 2022

Public Version Number

1

DI Record Publish Date

October 19, 2022

Package DI Number

50197106003372

Quantity per Package

2

Contains DI Package

10197106003374

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE