Catalog Number

136

Brand Name

Tilite Ceramic Alloys - Gamma Matt

Version/Model Number

136

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K894085

Product Code

EJH

Product Code Name

Alloy, Metal, Base

Public Device Record Key

5ee94d55-6eca-448d-8717-f6c1b6ea88db

Public Version Date

February 28, 2019

Public Version Number

1

DI Record Publish Date

January 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-