Catalog Number

-

Brand Name

Driva™

Version/Model Number

SPD41DSN

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

DZA

Product Code Name

DRILL, DENTAL, INTRAORAL

Public Device Record Key

513bef17-0eb8-4be2-bd52-43d4204c545e

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

August 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-