Catalog Number

ROSAS00126

Brand Name

STERILE ROBOT ARM INTERFACE

Version/Model Number

ROSA3-048A

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

K151359,K182848,K192173

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

c0632814-4a58-4407-a503-e120a9c4cd77

Public Version Date

July 12, 2022

Public Version Number

8

DI Record Publish Date

October 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-