Catalog Number

9521196

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9521196

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

FLG

Product Code Name

Cleaner, ultrasonic, medical instrument

Public Device Record Key

58917b4f-46a0-47bc-9b8d-13d4cf528b16

Public Version Date

March 19, 2021

Public Version Number

4

DI Record Publish Date

June 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-