Catalog Number

A0516-95

Brand Name

LEONE SPA

Version/Model Number

A0516-95

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

DYJ

Product Code Name

Retainer, Screw Expansion, Orthodontic

Public Device Record Key

f0fd4dbb-5b50-4fd1-8a83-23e07856e2d3

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

April 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-