Catalog Number

-

Brand Name

STOPCON Disposable Endoscope Valves Set

Version/Model Number

EN10229

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

bfae628d-302a-45c6-9c26-c8c24ddad421

Public Version Date

April 19, 2022

Public Version Number

1

DI Record Publish Date

April 11, 2022

Package DI Number

14897106951090

Quantity per Package

50

Contains DI Package

04897106951093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box