Catalog Number

000255

Brand Name

Creation Willi Geller

Version/Model Number

000255

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

K981490

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

b4f6a3e3-5e6a-40b3-ac26-1ecf746a606a

Public Version Date

July 24, 2018

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-