LEONE SPA - BRACKETS 25 DB MINI DIAG 18 T-7 BH - LEONE SPA

Duns Number:432167294

Device Description: BRACKETS 25 DB MINI DIAG 18 T-7 BH

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More Product Details

Catalog Number

F7370-25

Brand Name

LEONE SPA

Version/Model Number

F7370-25

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

EJF

Product Code Name

Bracket, Metal, Orthodontic

Device Record Status

Public Device Record Key

65812917-33f5-4052-8630-6ecd50a47d7d

Public Version Date

January 22, 2021

Public Version Number

2

DI Record Publish Date

January 07, 2021

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