Catalog Number

-

Brand Name

SINGLE USE BIOPSY VALVE (Sterile)

Version/Model Number

MAJ-210

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

K061313,K061313,K061313

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

387718f4-50f4-41b0-a129-211462cf1503

Public Version Date

December 24, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

54953170152431

Quantity per Package

70

Contains DI Package

14953170152433

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-