Catalog Number

9542662

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9542662

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

FRC

Product Code Name

Indicator, biological sterilization process

Public Device Record Key

0df66b44-7f67-4d92-a179-02e69af668f2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 31, 2016

Package DI Number

20889813000889

Quantity per Package

10

Contains DI Package

10889813000882

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case