Catalog Number

-

Brand Name

priti®multidisc ZrO2

Version/Model Number

13107-D985-20A35HT

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

K161025

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

6f7cf879-02c0-458c-a8ed-333713883dcf

Public Version Date

July 24, 2018

Public Version Number

4

DI Record Publish Date

March 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-