Catalog Number

70-19112 CLE

Brand Name

Color-Tip Saliva Ejectors Clear

Version/Model Number

70-19112 CLE

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

EHZ

Product Code Name

Evacuator, Oral Cavity

Public Device Record Key

49d6e92b-1648-421b-a785-8d41287cd33e

Public Version Date

August 13, 2018

Public Version Number

1

DI Record Publish Date

July 11, 2018

Package DI Number

00723896009550

Quantity per Package

10

Contains DI Package

00723896009543

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case