CLEARVIZ - CLEAR ORTHODONTIC PLASTIC/CERAMIC BRACKETS - Dyna Flex of Missouri, L.P.

Duns Number:006335558

Device Description: CLEAR ORTHODONTIC PLASTIC/CERAMIC BRACKETS

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More Product Details

Catalog Number

-

Brand Name

CLEARVIZ

Version/Model Number

2188XX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

NJM

Product Code Name

Bracket, Ceramic, Orthodontic

Device Record Status

Public Device Record Key

775cfd63-8939-47b0-997a-a21ed867de39

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 10, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DYNA FLEX OF MISSOURI, L.P." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13