Catalog Number

-

Brand Name

NAVIGATED INSTRUMENTS;FIREBIRD NXG

Version/Model Number

36-1341

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

K172115

Product Code

OLO

Product Code Name

Orthopedic stereotaxic instrument

Public Device Record Key

ffc4c945-f642-4bed-bba8-b2452bd2c86b

Public Version Date

March 27, 2019

Public Version Number

1

DI Record Publish Date

March 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-