ROBOT ROSA ONE (USA) - "Standard ROSA® ONE Surgical Assistant device( - MEDTECH

Duns Number:264502977

Device Description: "Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch scree "Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm)120 V - 60 Hz - Plug B"

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

ROSAS00203

Brand Name

ROBOT ROSA ONE (USA)

Version/Model Number

3.1.4.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K192173,K200511

Product Code Details

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Device Record Status

Public Device Record Key

cd996bed-bb47-4765-be78-26d47239fa75

Public Version Date

October 02, 2020

Public Version Number

2

DI Record Publish Date

July 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTECH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 251