Catalog Number

MU5-U5X

Brand Name

American Eagle Instruments

Version/Model Number

MU5-U5X

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

EMN

Product Code Name

SCALER, PERIODONTIC

Public Device Record Key

48bd9534-7cf8-4139-9602-30dc2ab71c13

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

-