Catalog Number

-

Brand Name

priti®multidisc ZrO2

Version/Model Number

MZRD3016

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100250

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

6bb5b158-f256-49f0-916e-65f1fb65c3c8

Public Version Date

March 19, 2021

Public Version Number

1

DI Record Publish Date

March 11, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-