Catalog Number

0450395805

Brand Name

MatrixMIDFACE

Version/Model Number

04.503.958.05

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

K050608,K050608

Product Code

JEY

Product Code Name

PLATE, BONE

Public Device Record Key

c0a081a9-d738-41c7-9be0-f42a8df9badf

Public Version Date

April 25, 2022

Public Version Number

2

DI Record Publish Date

December 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-