Catalog Number

-

Brand Name

CFCPX

Version/Model Number

8800-81

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"

Yes

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

K042458,K042458

Product Code

LXT

Product Code Name

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

Public Device Record Key

57aaa30e-f285-4357-a1c5-b357b0318648

Public Version Date

May 16, 2019

Public Version Number

2

DI Record Publish Date

September 03, 2018

Package DI Number

00857915007392

Quantity per Package

1

Contains DI Package

00857915007019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit