Catalog Number

-

Brand Name

STOPCON Disposable Endoscope Valves Set

Version/Model Number

EN10229PB

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ODC

Product Code Name

Endoscope Channel Accessory

Public Device Record Key

f21564bb-cadb-420f-a499-6130054d02ee

Public Version Date

January 10, 2022

Public Version Number

2

DI Record Publish Date

December 08, 2021

Package DI Number

14897106954091

Quantity per Package

50

Contains DI Package

04897106954094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box