LEONE SPA - EXORAL FACEBOW 045 LOOPS LONG n. 1 - LEONE SPA

Duns Number:432167294

Device Description: EXORAL FACEBOW 045 LOOPS LONG n. 1

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More Product Details

Catalog Number

M4805P01

Brand Name

LEONE SPA

Version/Model Number

M4805P01

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

DZB

Product Code Name

Headgear, Extraoral, Orthodontic

Device Record Status

Public Device Record Key

641bb3a1-36d6-4c8d-8d88-f9a467bde1d0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 14, 2017

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