Catalog Number

DDK2-2.4-16X

Brand Name

Disposable Drill Kit

Version/Model Number

DDK2-2.4-16X

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

HBE

Product Code Name

DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Public Device Record Key

99bf1525-f5ad-4210-83ce-80f5e7544a3e

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

December 27, 2017

Package DI Number

90841823101146

Quantity per Package

2

Contains DI Package

00841823101143

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-