Catalog Number

3DD20H

Brand Name

Diamond Drill

Version/Model Number

3DD20H

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

DZA

Product Code Name

Drill, Dental, Intraoral

Public Device Record Key

aa038d45-2803-4628-8340-cf9f2a9a13fb

Public Version Date

January 09, 2020

Public Version Number

4

DI Record Publish Date

June 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-