Catalog Number

2629

Brand Name

Plak-Vac

Version/Model Number

2629

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

0d87d140-059d-469c-8b71-b45140617975

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 17, 2019

Package DI Number

B23926291

Quantity per Package

24

Contains DI Package

B23926290

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case