Catalog Number

595915AN

Brand Name

ApexCal

Version/Model Number

595915AN

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

-

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

f2fe16b3-0dc7-42f5-b579-60e2abbe9800

Public Version Date

October 06, 2022

Public Version Number

2

DI Record Publish Date

August 18, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-