Catalog Number

-

Brand Name

Comfort Plus™ Premium Saliva Ejectors

Version/Model Number

ZWGCPM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

0750dca0-bcfe-48f4-a4df-104e08427db2

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Package DI Number

50732224000843

Quantity per Package

10

Contains DI Package

10732224000845

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-