Driva™ - ZIMMER DENTAL INC.

Duns Number:103167086

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More Product Details

Catalog Number

-

Brand Name

Driva™

Version/Model Number

SV3.4DN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DZA

Product Code Name

DRILL, DENTAL, INTRAORAL

Device Record Status

Public Device Record Key

87eb3f14-65c8-467c-9048-c3b47eca2be7

Public Version Date

March 10, 2022

Public Version Number

5

DI Record Publish Date

August 18, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZIMMER DENTAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 312
2 A medical device with a moderate to high risk that requires special controls. 724