Catalog Number

-

Brand Name

1.2mL Unit Dose EDTA Kit

Version/Model Number

317002

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

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

KJJ

Product Code Name

Cleanser, Root Canal

Public Device Record Key

e7200ef1-dffc-4b68-ac41-4168b9485664

Public Version Date

January 29, 2021

Public Version Number

1

DI Record Publish Date

January 21, 2021

Package DI Number

20818207020561

Quantity per Package

12

Contains DI Package

10818207020564

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-