Catalog Number

-

Brand Name

YelloPort Plus - Laparoscopic Port Access System

Version/Model Number

YA512STSA

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"

-

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

K070712,K070712

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

aa3ce411-0dba-44ce-806a-29894db91c31

Public Version Date

March 30, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

05051986006567

Quantity per Package

6

Contains DI Package

05051986004921

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box