Catalog Number

-

Brand Name

discovery®

Version/Model Number

891-405-00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 23, 2017

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

K935139

Product Code

EJF

Product Code Name

BRACKET, METAL, ORTHODONTIC

Public Device Record Key

bbf499dc-237c-4443-be9e-30de7dfd9c63

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-