Catalog Number

2647

Brand Name

Plak-Vac

Version/Model Number

2647

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

b62890b2-5a4f-41d9-9633-5a98edeb2199

Public Version Date

December 06, 2018

Public Version Number

1

DI Record Publish Date

November 05, 2018

Package DI Number

B26926471

Quantity per Package

100

Contains DI Package

B23926470

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case