Catalog Number

9908816

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9908816

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

-

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

EKI

Product Code Name

CARRIER, AMALGAM, OPERATIVE

Public Device Record Key

c0cd6c0a-9fa3-4233-bc2c-d006c415e18d

Public Version Date

August 02, 2019

Public Version Number

1

DI Record Publish Date

July 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-