Catalog Number

-

Brand Name

Stealth Midas™

Version/Model Number

EM200N

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

K160713

Product Code

OLO

Product Code Name

Orthopedic stereotaxic instrument

Public Device Record Key

65a87056-66e8-47e2-9098-1b65ae158ff3

Public Version Date

November 15, 2018

Public Version Number

1

DI Record Publish Date

October 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-