Catalog Number

3019

Brand Name

Plak-Vac

Version/Model Number

3019

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NXZ

Product Code Name

Dental Hygiene Kit

Public Device Record Key

8e6301ad-5e26-430f-90e0-b708e8684805

Public Version Date

April 17, 2019

Public Version Number

1

DI Record Publish Date

April 09, 2019

Package DI Number

B23930191

Quantity per Package

100

Contains DI Package

B23930190

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case