Catalog Number

D38124

Brand Name

Plaquit

Version/Model Number

D38124

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K162408

Product Code

EBD

Product Code Name

Coating, Filling Material, Resin

Public Device Record Key

7cec954b-9aa5-4599-b6d9-32abd2ccf676

Public Version Date

August 22, 2022

Public Version Number

4

DI Record Publish Date

April 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-