Catalog Number

-

Brand Name

Vilex Drill Cannulated

Version/Model Number

Z402-100-22

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

K014154,K991197

Product Code

HTW

Product Code Name

Bit, Drill

Public Device Record Key

7537cd2c-de45-401c-a0b8-827ff61bc659

Public Version Date

May 27, 2020

Public Version Number

7

DI Record Publish Date

January 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-