Tanzo - WIRE TANZO MID FORM A MD LOWER 013 10/PK - AMERICAN ORTHODONTICS CORPORATION

Duns Number:044668515

Device Description: WIRE TANZO MID FORM A MD LOWER 013 10/PK

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

827-AMDL-13

Brand Name

Tanzo

Version/Model Number

827-AMDL-13

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 25, 2019

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

DZC

Product Code Name

WIRE, ORTHODONTIC

Device Record Status

Public Device Record Key

e0ffab3c-36a6-4a55-93ee-e56cb4a98451

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

October 20, 2017

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