Catalog Number

04503149S

Brand Name

MatrixNEURO

Version/Model Number

04.503.149S

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

K123723

Product Code

GWO

Product Code Name

Plate, cranioplasty, preformed, alterable

Public Device Record Key

79a24d3b-b6ee-4396-8aa8-00c56178c914

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-