Catalog Number

3035

Brand Name

Plak-Vac

Version/Model Number

3035

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

815a8be6-e329-4121-8ea3-d47a9e2f81d1

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 15, 2019

Package DI Number

B23930351

Quantity per Package

24

Contains DI Package

B23930350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case