Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

300BC

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

DYN

Product Code Name

Mouthpiece, Saliva Ejector

Public Device Record Key

b5939237-783f-4a9d-8c4f-41855e4b1a9b

Public Version Date

May 27, 2019

Public Version Number

1

DI Record Publish Date

May 19, 2019

Package DI Number

D838300BC6

Quantity per Package

10

Contains DI Package

D838300BC4

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner case