Catalog Number

DTRC-32S

Brand Name

PLEUR-EVAC

Version/Model Number

IPN011533

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

040f0ac2-6f4d-48cf-9f36-224da145c4bd

Public Version Date

February 28, 2020

Public Version Number

2

DI Record Publish Date

September 15, 2018

Package DI Number

24026704558562

Quantity per Package

10

Contains DI Package

04026704558568

Package Discontinue Date

October 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Box