Catalog Number

9508278

Brand Name

Darby Dental Supply, LLC

Version/Model Number

D109

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PEM

Product Code Name

Dental barriers and sleeves

Public Device Record Key

0deaa9ac-cc5b-437d-b866-5d6c87cb4090

Public Version Date

November 08, 2018

Public Version Number

3

DI Record Publish Date

June 24, 2016

Package DI Number

20889813001398

Quantity per Package

6

Contains DI Package

10889813001391

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-