Catalog Number

-

Brand Name

VITA LUMEX

Version/Model Number

BLCBK

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

K193434

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Public Device Record Key

9909afe5-1ac4-4cb8-a1d7-7adef391af5d

Public Version Date

August 12, 2020

Public Version Number

1

DI Record Publish Date

August 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-