Catalog Number

160130

Brand Name

Bard® Syringe Assist Irrigation System

Version/Model Number

160130

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)

Yes

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

OCX

Product Code Name

endoscopic irrigation/suction system

Public Device Record Key

9186853e-4968-428d-8f06-412febf7c823

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 19, 2016

Package DI Number

10801741045759

Quantity per Package

12

Contains DI Package

00801741045752

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA