Sierra Cosmetic Brackets - COSMETIC SIERRA UL BICUSPID 022 T-7 A=0 R=0 W/HK - AMERICAN ORTHODONTICS CORPORATION

Duns Number:044668515

Device Description: COSMETIC SIERRA UL BICUSPID 022 T-7 A=0 R=0 W/HK DIST

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More Product Details

Catalog Number

002-9811HV

Brand Name

Sierra Cosmetic Brackets

Version/Model Number

002-9811HV

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 01, 2017

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

6abc78f5-7d8c-4eb1-8076-72ad967cbbcd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMERICAN ORTHODONTICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16634
2 A medical device with a moderate to high risk that requires special controls. 982