Catalog Number

-

Brand Name

NORDENT MANUFACTURING INC.

Version/Model Number

CECNMORT2

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EKG

Product Code Name

Condenser, Amalgam And Foil, Operative

Public Device Record Key

f36e7df4-a68b-4549-ba5c-f35395c8bd29

Public Version Date

January 25, 2021

Public Version Number

1

DI Record Publish Date

January 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-