Catalog Number

ROB00032

Brand Name

NAVIO

Version/Model Number

ROB00032

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

5658a01e-a826-4030-bdc5-dee374371561

Public Version Date

April 26, 2022

Public Version Number

3

DI Record Publish Date

July 25, 2017

Package DI Number

20885556685321

Quantity per Package

3

Contains DI Package

00885556685327

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX