Catalog Number

-

Brand Name

NORDENT MANUFACTURING INC

Version/Model Number

AC3EZ

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

EKI

Product Code Name

Carrier, Amalgam, Operative

Public Device Record Key

2c0fc104-b1be-44af-a462-b118d15fe5ce

Public Version Date

June 17, 2020

Public Version Number

1

DI Record Publish Date

June 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-