Catalog Number

E0017815-2

Brand Name

Ex-Fix

Version/Model Number

E0017815-2

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

K994143

Product Code

JDW

Product Code Name

PIN, FIXATION, THREADED

Public Device Record Key

a3ba2a4c-4451-4773-aee4-2f0453c0464c

Public Version Date

September 13, 2022

Public Version Number

1

DI Record Publish Date

September 05, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-