Catalog Number

-

Brand Name

N/A

Version/Model Number

PP-0444

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

K131674,K113512,K063052

Product Code

DZJ

Product Code Name

Driver, Wire, And Bone Drill, Manual

Public Device Record Key

30570cfe-f0f1-47d7-8b5b-37b57aec2aa0

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

May 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-