Dríva™ Gold Series Drills - DRIVA™ GOLD SERIES STEP DRILL, 3.4/2.8MM X 22MM - BIOMET 3I, LLC

Duns Number:186127825

Device Description: DRIVA™ GOLD SERIES STEP DRILL, 3.4/2.8MM X 22MM

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More Product Details

Catalog Number

-

Brand Name

Dríva™ Gold Series Drills

Version/Model Number

TSV34D28G

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

4e2891bb-b67b-4f18-be10-020cd8261dbe

Public Version Date

March 10, 2022

Public Version Number

2

DI Record Publish Date

July 14, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMET 3I, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 899
2 A medical device with a moderate to high risk that requires special controls. 1962