Catalog Number

3410964

Brand Name

Darby Dental Supply, LLC

Version/Model Number

3410964

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

KHR

Product Code Name

ABSORBER, SALIVA, PAPER

Public Device Record Key

79159eb9-7f8c-4159-ba6c-f375570623d6

Public Version Date

September 02, 2019

Public Version Number

1

DI Record Publish Date

August 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-