Catalog Number

2227

Brand Name

Vision-Zirkon

Version/Model Number

2227

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

366b2602-0fea-4ddd-8ba6-25938e5ed8d4

Public Version Date

November 04, 2019

Public Version Number

3

DI Record Publish Date

November 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-