Catalog Number

2393

Brand Name

Vision-Zirkon

Version/Model Number

2393

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

K990790

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

d63565c5-8efd-4d03-9f74-3a0af93ffe94

Public Version Date

November 04, 2019

Public Version Number

3

DI Record Publish Date

November 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-