Catalog Number

-

Brand Name

Noritake Super Porcelain EX-3

Version/Model Number

126-0011KA

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K193060

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

7158ce55-bf55-4a62-9d79-637be87b39f6

Public Version Date

August 10, 2021

Public Version Number

6

DI Record Publish Date

November 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-