Catalog Number

1068935

Brand Name

Henry Schein

Version/Model Number

1068935

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

9bda5b87-404f-48d2-80bd-393c234ee98a

Public Version Date

September 19, 2019

Public Version Number

1

DI Record Publish Date

September 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-