Catalog Number

366835

Brand Name

ROEKO Calcium Hydroxide PLUS Points

Version/Model Number

ISO 35

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2021

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

Yes

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

EJK

Product Code Name

Liner, Cavity, Calcium Hydroxide

Public Device Record Key

9485568e-b88b-4208-9c8a-d5e81ad34e8c

Public Version Date

March 25, 2022

Public Version Number

4

DI Record Publish Date

February 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-