Catalog Number

ST19

Brand Name

Standard Trocar

Version/Model Number

ST19-1

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

K200517,K200517

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

e225376e-2d0a-47b6-b263-861c4e5aa802

Public Version Date

August 19, 2021

Public Version Number

2

DI Record Publish Date

April 27, 2020

Package DI Number

10851677007048

Quantity per Package

6

Contains DI Package

00851677007041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-