Catalog Number

-

Brand Name

OrthoFX

Version/Model Number

Z1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 08, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NXC

Product Code Name

Aligner, Sequential

Public Device Record Key

0cda8ac7-01ee-4804-9a65-27349b4923f1

Public Version Date

January 03, 2022

Public Version Number

4

DI Record Publish Date

February 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-