Catalog Number

SMA11PGHKF

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA11PGHKF

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

f826cfe2-e9f3-4068-938d-5f071057519e

Public Version Date

July 17, 2018

Public Version Number

3

DI Record Publish Date

August 12, 2016

Package DI Number

50885425951213

Quantity per Package

8

Contains DI Package

10885425951215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE