Catalog Number

100135

Brand Name

ENDOGATOR

Version/Model Number

100135

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 25, 2022

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

K033695,K033695,K033695

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

e9c75642-5dfa-4074-b956-6e97c731f870

Public Version Date

May 26, 2022

Public Version Number

9

DI Record Publish Date

September 22, 2016

Package DI Number

10677964058957

Quantity per Package

10

Contains DI Package

00677964058950

Package Discontinue Date

May 25, 2022

Package Status

Not in Commercial Distribution

Package Type

Carton