Catalog Number

403001

Brand Name

OrthAlign Plus

Version/Model Number

403001

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

58482a27-6df9-491a-86eb-f691aacf463e

Public Version Date

January 06, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10858704006531

Quantity per Package

5

Contains DI Package

00858704006534

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box