Catalog Number

31124

Brand Name

NA

Version/Model Number

311.24

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

K150796

Product Code

DZJ

Product Code Name

DRIVER, WIRE, AND BONE DRILL, MANUAL

Public Device Record Key

9563945d-b169-4b8e-a3cb-c3c05fef7910

Public Version Date

April 25, 2022

Public Version Number

4

DI Record Publish Date

June 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-