Catalog Number

-

Brand Name

CO2 Hose and Yoke Shuttle Valve System

Version/Model Number

7-510-50

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

K022052

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

8f8f54d3-a01c-4586-a9ca-e095b73eced2

Public Version Date

July 04, 2022

Public Version Number

4

DI Record Publish Date

October 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-