Catalog Number

100110

Brand Name

ENDOGATOR

Version/Model Number

100110

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K033695

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

607b87a9-060b-4ae9-9544-bec9a86c6f1c

Public Version Date

May 26, 2022

Public Version Number

7

DI Record Publish Date

August 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-