Catalog Number

-

Brand Name

IRRIGATOR/INSUFFLATOR

Version/Model Number

EGA-7015

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 12, 2018

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

K113119

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

e8624ce0-633e-4ae9-9b1f-85c6ef552a57

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-