Catalog Number

9519255

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9519255

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

d76ef89a-f951-4018-ab73-bd82231a26a7

Public Version Date

June 13, 2019

Public Version Number

1

DI Record Publish Date

June 05, 2019

Package DI Number

20889813023628

Quantity per Package

10

Contains DI Package

00889813023624

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-