Catalog Number

E2205-13

Brand Name

LEONE SPA

Version/Model Number

E2205-13

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

cf8e967c-dbcd-4e23-9a15-181f1f3aae44

Public Version Date

July 28, 2020

Public Version Number

1

DI Record Publish Date

July 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-