Catalog Number

-

Brand Name

Vilex Drill Cannulated

Version/Model Number

DA2018

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

K041287,K112837

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

2d0e41cc-7eb0-46d6-88b4-04c08b012b21

Public Version Date

May 27, 2020

Public Version Number

7

DI Record Publish Date

January 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-