Catalog Number

199-1063

Brand Name

SELECT TEMPORARY CEMENT TUBE PKG EUGENOL

Version/Model Number

199-1063

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 11, 2018

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

-

Product Code

EMB

Product Code Name

Zinc Oxide Eugenol

Public Device Record Key

7e0fff70-17f7-40f5-b6c7-1d63aedc5779

Public Version Date

December 04, 2018

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-