Comp Plus Six™ 1 Case Lower Bracket Kit-Lab Use - 1 Set Of Lower Direct Bond Composite Brackets - ORTHO SPECIALTIES

Duns Number:011050583

Device Description: 1 Set Of Lower Direct Bond Composite Brackets With Stainless Steel Molar Tubes

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More Product Details

Catalog Number

720-562

Brand Name

Comp Plus Six™ 1 Case Lower Bracket Kit-Lab Use

Version/Model Number

720-562

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

48decc5b-60d1-4c6e-8e62-830fb843e615

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