Catalog Number

-

Brand Name

ENDOGATOR

Version/Model Number

100125

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

-

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

ead7d2ec-dcb8-4b11-9673-5f3985f9e3e3

Public Version Date

April 27, 2022

Public Version Number

8

DI Record Publish Date

September 22, 2016

Package DI Number

20677964058442

Quantity per Package

50

Contains DI Package

00677964058448

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case