Catalog Number

403001

Brand Name

OrthAlign Plus

Version/Model Number

403001-05

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"

Yes

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

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

4b45fb7f-96cf-46fa-9a33-c07be2b5610a

Public Version Date

January 06, 2020

Public Version Number

5

DI Record Publish Date

October 13, 2017

Package DI Number

00851977007918

Quantity per Package

5

Contains DI Package

00851977007901

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case