Catalog Number

-

Brand Name

Pentax Irrigation Pump

Version/Model Number

EGP-100P

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

K060962,K060962

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

e027f66a-57aa-47c4-b73f-bdf762d91804

Public Version Date

April 27, 2022

Public Version Number

6

DI Record Publish Date

May 04, 2017

Package DI Number

30677964085605

Quantity per Package

1

Contains DI Package

00677964085604

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-