Compliance Spring - FIXED FUNCT MINI SCREW SPRING 018 FOR BITE - AMERICAN ORTHODONTICS CORPORATION

Duns Number:044668515

Device Description: FIXED FUNCT MINI SCREW SPRING 018 FOR BITE OPENING 10/PKG

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More Product Details

Catalog Number

855-212

Brand Name

Compliance Spring

Version/Model Number

855-212

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 25, 2021

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

ECO

Product Code Name

Spring, Orthodontic

Device Record Status

Public Device Record Key

090f0376-ee2c-4909-92cd-422af0cb91bf

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

April 16, 2019

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