Catalog Number

ROSAS00517

Brand Name

Planning station ROSA BRain

Version/Model Number

164017

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K172444

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

a10bb49b-df33-4f5f-8482-5bbb649d35d4

Public Version Date

October 02, 2020

Public Version Number

2

DI Record Publish Date

September 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-