Catalog Number

9515213

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9515213

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"

Yes

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

FXX

Product Code Name

Mask, surgical

Public Device Record Key

9f492638-97a6-4754-9d26-a57d091fdd63

Public Version Date

May 06, 2020

Public Version Number

3

DI Record Publish Date

November 22, 2017

Package DI Number

00889813010884

Quantity per Package

10

Contains DI Package

00889813010846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case