Catalog Number

ICGS 020

Brand Name

IRRAflow® 2.0 Catheter

Version/Model Number

ICGS 020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171880,K171880

Product Code

GWM

Product Code Name

Device, Monitoring, Intracranial Pressure

Public Device Record Key

a034dc59-94a2-43aa-84e7-22b0c1e784fe

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

January 22, 2019

Package DI Number

10868643000439

Quantity per Package

10

Contains DI Package

00868643000432

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box