Catalog Number

DCS 010

Brand Name

IRRAflow® Drainage Collection System

Version/Model Number

DCS 010

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)

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

ad59ad51-42f2-41c6-a19b-984370ab02ca

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 30, 2019

Package DI Number

10868643000477

Quantity per Package

1

Contains DI Package

00868643000470

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box