Catalog Number

475-1112

Brand Name

Empower2

Version/Model Number

475-1112

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EJF

Product Code Name

Bracket, Metal, Orthodontic

Public Device Record Key

bdbe2c02-28aa-426f-9508-bf8b0456ea81

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

December 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-