Catalog Number

000523

Brand Name

Disposable Biopsy Valve

Version/Model Number

MDBV1B0000A

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

K173758,K173758,K173758

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

f7ff761b-0a5b-4587-acce-dbbc8c829003

Public Version Date

July 18, 2022

Public Version Number

3

DI Record Publish Date

June 18, 2019

Package DI Number

26970401814071

Quantity per Package

500

Contains DI Package

16970401814067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case