Catalog Number

-

Brand Name

Kick 2 EM Navigation Station

Version/Model Number

18190

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K183605

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

3e9d5753-8015-4d60-a516-3468722a56d9

Public Version Date

February 21, 2020

Public Version Number

1

DI Record Publish Date

February 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-