Catalog Number

-

Brand Name

Vilex Jones Fracture Tool

Version/Model Number

JF-DEPTH-200

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

-

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

K191289

Product Code

HTJ

Product Code Name

Gauge, Depth

Public Device Record Key

2a322082-751a-4cf1-b802-05ec3e4ee3a4

Public Version Date

May 27, 2020

Public Version Number

4

DI Record Publish Date

August 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-