Catalog Number

-

Brand Name

Vilex Jones Fracture Guidewire

Version/Model Number

K200-18S

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

K191289

Product Code

HXI

Product Code Name

Passer, Wire, Orthopedic

Public Device Record Key

8c7a5d83-b19c-45b4-b865-7bdd6ea2ed76

Public Version Date

May 27, 2020

Public Version Number

4

DI Record Publish Date

March 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-