Catalog Number

ROSAS00203

Brand Name

ROSA One

Version/Model Number

3.1.0.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 16, 2019

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

K182417

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

60fd969e-c835-4e31-a7c7-3b8d200595bd

Public Version Date

October 02, 2020

Public Version Number

3

DI Record Publish Date

May 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-