Catalog Number

E8700-08

Brand Name

LEONE SPA

Version/Model Number

E8700-08

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

ECM

Product Code Name

Band, Preformed, Orthodontic

Public Device Record Key

5ac3a122-af6a-49c0-a7b5-843c4bc93bd2

Public Version Date

August 27, 2020

Public Version Number

1

DI Record Publish Date

August 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-