Catalog Number

DSTC-32S

Brand Name

PLEUR-EVAC

Version/Model Number

IPN011518

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

e13a497a-e747-4ae3-afe0-590a8c1eb3b5

Public Version Date

January 29, 2020

Public Version Number

2

DI Record Publish Date

September 15, 2018

Package DI Number

24026704558456

Quantity per Package

10

Contains DI Package

04026704558452

Package Discontinue Date

January 20, 2020

Package Status

Not in Commercial Distribution

Package Type

Box