Catalog Number

760184-STM

Brand Name

Ceramill® ZI

Version/Model Number

ZI 20mm

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 2020

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"

Yes

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

K063511

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

3d52d63e-47d7-40a5-89b2-977aa81c1619

Public Version Date

October 16, 2020

Public Version Number

4

DI Record Publish Date

December 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-