Catalog Number

8881450004

Brand Name

Argyle

Version/Model Number

8881450004

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)

Yes

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

52914890-aa8a-4c03-ba0e-0d6bc107a56b

Public Version Date

February 15, 2019

Public Version Number

3

DI Record Publish Date

June 30, 2018

Package DI Number

20884521020334

Quantity per Package

1000

Contains DI Package

10884521020337

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE