Catalog Number

40-2460-R014X

Brand Name

FEM

Version/Model Number

40-2460-R014X

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

91812d53-1d97-4120-b15a-580fda67afb6

Public Version Date

November 01, 2021

Public Version Number

1

DI Record Publish Date

October 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-