Catalog Number

-

Brand Name

ReFlow Ventricular System

Version/Model Number

A0011

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

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

K172006,K172006

Product Code

JXG

Product Code Name

Shunt, Central Nervous System And Components

Public Device Record Key

a57e96b9-f850-410f-97e0-5104ef24507d

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

October 02, 2018

Package DI Number

00860024001816

Quantity per Package

2

Contains DI Package

00860024001809

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Overshipper