Catalog Number

2632

Brand Name

Plak-Vac

Version/Model Number

2632

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

339a211a-48f7-43d0-a4b7-9382d895ed40

Public Version Date

January 04, 2019

Public Version Number

1

DI Record Publish Date

December 04, 2018

Package DI Number

B23926321

Quantity per Package

100

Contains DI Package

B23926320

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case