Catalog Number

-

Brand Name

Drill S-3.3, 2.5/1.8mmDx18.0mmL

Version/Model Number

GSN1825

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

EJL

Product Code Name

Bur, Dental

Public Device Record Key

e4999a70-6dba-45c2-8e4a-79842a1cc7cd

Public Version Date

April 19, 2021

Public Version Number

1

DI Record Publish Date

April 11, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-