Catalog Number

45491216

Brand Name

TRUFIX Bone Fixation System

Version/Model Number

45491216

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

K061397,K061397

Product Code

OAT

Product Code Name

Implant, endosseous, orthodontic

Public Device Record Key

8011e4e6-5a75-4b9c-9e48-c64dd28b2f14

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

10614950006448

Quantity per Package

5

Contains DI Package

00614950006441

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvec Bag