Catalog Number

-

Brand Name

SmartArch

Version/Model Number

SAO-DROL-0016

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

DZC

Product Code Name

Wire, Orthodontic

Public Device Record Key

f254a972-e967-46df-b9d3-6971139ac031

Public Version Date

April 13, 2021

Public Version Number

1

DI Record Publish Date

April 05, 2021

Package DI Number

D948SAODROL00161

Quantity per Package

10

Contains DI Package

D948SAODROL00160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Envelope