Eaglewear - HIGH PULL RELEASE MODULE - EAGLEWEAR CLEAR 10/PKG - AMERICAN ORTHODONTICS CORPORATION

Duns Number:044668515

Device Description: HIGH PULL RELEASE MODULE - EAGLEWEAR CLEAR 10/PKG

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More Product Details

Catalog Number

852-828

Brand Name

Eaglewear

Version/Model Number

852-828

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 09, 2020

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

2db47fe3-a0ed-45e8-a897-3f671bd9af01

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

December 07, 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