Catalog Number

-

Brand Name

ENDOGATOR Kit

Version/Model Number

100623B

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

K102855,K102855

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

de4058b0-a869-4acf-8018-c5cf5c23805b

Public Version Date

April 27, 2022

Public Version Number

6

DI Record Publish Date

August 16, 2018

Package DI Number

20677964067383

Quantity per Package

20

Contains DI Package

00677964067389

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case