Catalog Number

-

Brand Name

AMERICAN ORTHODONTICS

Version/Model Number

200-109

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ECP

Product Code Name

Instrument, Ligature Tucking, Orthodontic

Public Device Record Key

cae163bc-7cdb-40c1-8569-a270d79e0f74

Public Version Date

May 06, 2020

Public Version Number

1

DI Record Publish Date

April 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-