Catalog Number

-

Brand Name

N/A

Version/Model Number

PP-0459

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

K063052,K113512,K131674

Product Code

DZJ

Product Code Name

Driver, Wire, And Bone Drill, Manual

Public Device Record Key

4b8fca24-add7-495f-8682-e68133276faa

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-