Catalog Number

-

Brand Name

OPTIMUM

Version/Model Number

4448-886

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

EKS

Product Code Name

File, Pulp Canal, Endodontic

Public Device Record Key

c958c3e4-6572-4226-ae87-5d3177d578c9

Public Version Date

December 07, 2018

Public Version Number

2

DI Record Publish Date

October 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-