Catalog Number

AEMCC/P1TNZ

Brand Name

American Eagle Instruments

Version/Model Number

AEMCC/P1TNZ

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

EKR

Product Code Name

Plugger, Root Canal, Endodontic

Public Device Record Key

d8cc1826-c451-440e-80d3-2b4b837f0629

Public Version Date

October 05, 2022

Public Version Number

3

DI Record Publish Date

July 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-