Catalog Number

2392

Brand Name

Plak-Vac

Version/Model Number

2392

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

4fb8889b-42b6-4860-a353-2de88fa63c97

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 31, 2019

Package DI Number

B23923921

Quantity per Package

100

Contains DI Package

B23923920

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case