Catalog Number

403402

Brand Name

OrthAlign Plus

Version/Model Number

403402

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"

-

For Single-Use

-

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

6deac2ef-4eea-41ee-9361-f7c4d88c7f12

Public Version Date

January 06, 2020

Public Version Number

4

DI Record Publish Date

October 10, 2017

Package DI Number

10851977007847

Quantity per Package

1

Contains DI Package

00851977007840

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack (P/N 403405)