Catalog Number

SMA43OLTSF

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA43OLTSF

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

026b7e55-9fc3-4a7c-b91a-78111d031499

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

September 28, 2017

Package DI Number

50887488824640

Quantity per Package

2

Contains DI Package

10887488824642

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE