Catalog Number

54-11540

Brand Name

TRUELOK SYSTEM

Version/Model Number

1

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

K941048

Product Code

LXT

Product Code Name

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Public Device Record Key

c06085ef-2fac-4902-83ff-4dfbf85833ce

Public Version Date

November 23, 2021

Public Version Number

3

DI Record Publish Date

April 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-