Catalog Number

-

Brand Name

American Eagle Instruments

Version/Model Number

AEMHRKIT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 29, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EJB

Product Code Name

HANDLE, INSTRUMENT, DENTAL

Public Device Record Key

53df4df1-ba69-469d-96e7-70a41af36fe0

Public Version Date

October 05, 2022

Public Version Number

4

DI Record Publish Date

December 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-