Catalog Number

-

Brand Name

CPX

Version/Model Number

8800-90

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

Product Code

LXT

Product Code Name

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

Public Device Record Key

2df92f8a-369d-4d8a-afc9-191a604fdda3

Public Version Date

March 25, 2019

Public Version Number

1

DI Record Publish Date

March 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-