LEONE SPA - PALATAL EXPANSION SCREW 9mm GL. - LEONE SPA

Duns Number:432167294

Device Description: PALATAL EXPANSION SCREW 9mm GL.

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More Product Details

Catalog Number

A0620G909

Brand Name

LEONE SPA

Version/Model Number

A0620G909

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DYJ

Product Code Name

Retainer, Screw Expansion, Orthodontic

Device Record Status

Public Device Record Key

760f95d7-56e7-41d8-9406-eb9ec945b963

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

May 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LEONE SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6976
2 A medical device with a moderate to high risk that requires special controls. 689