Catalog Number

3045

Brand Name

Plak-Vac

Version/Model Number

3045

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

297a9d2e-99a7-42da-ba5c-768e4fdb3791

Public Version Date

February 24, 2020

Public Version Number

1

DI Record Publish Date

February 14, 2020

Package DI Number

B23930451

Quantity per Package

24

Contains DI Package

B23930450

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case