Catalog Number

DTRC-28S

Brand Name

PLEUR-EVAC

Version/Model Number

IPN011532

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

-

Product Code

GBX

Product Code Name

CATHETER, IRRIGATION

Public Device Record Key

c3087301-913f-4d86-9531-9cdbab560639

Public Version Date

March 02, 2020

Public Version Number

2

DI Record Publish Date

September 15, 2018

Package DI Number

24026704558555

Quantity per Package

10

Contains DI Package

04026704558551

Package Discontinue Date

October 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Box