Catalog Number

MEN01US

Brand Name

RocaFlow - Irrigation and Warming System - Single Chamber

Version/Model Number

09-0053

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

-

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

c0fee546-9ae7-4b35-9b10-4067cadd04ea

Public Version Date

November 11, 2019

Public Version Number

4

DI Record Publish Date

November 09, 2017

Package DI Number

03700512956174

Quantity per Package

1

Contains DI Package

03700512955177

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box