.022 UL Cuspid Comp Clear Six™ - Upper Left Cuspid .022 Direct Bond Composite - ORTHO SPECIALTIES

Duns Number:011050583

Device Description: Upper Left Cuspid .022 Direct Bond Composite Orthodontic Bracket

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More Product Details

Catalog Number

710-605

Brand Name

.022 UL Cuspid Comp Clear Six™

Version/Model Number

710-605

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

DYW

Product Code Name

Bracket, Plastic, Orthodontic

Device Record Status

Public Device Record Key

5bc4b214-1754-4cdb-9e36-b47185e2c720

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO SPECIALTIES" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 67