Catalog Number

C1230-95

Brand Name

LEONE SPA

Version/Model Number

C1230-95

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

DZD

Product Code Name

Tube, Orthodontic

Public Device Record Key

0b63397f-0847-445f-aed4-8afbcd8f7315

Public Version Date

May 26, 2020

Public Version Number

1

DI Record Publish Date

May 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-