Catalog Number

45428003

Brand Name

TRUFIX Bone Fixation System

Version/Model Number

45428003

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

K080074,K080074

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

4cb18d52-756e-48d6-8c6d-91bd88d71156

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

June 20, 2017

Package DI Number

10614950006196

Quantity per Package

5

Contains DI Package

00614950006199

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvec Bag