Duns Number:264502977
Device Description: ROSA PLANNING STATIONLaptop computer with the following minimal configuration : Windows 7, ROSA PLANNING STATIONLaptop computer with the following minimal configuration : Windows 7, intel Pentium processor, 15,6'' screen, DVD +/- RW, USB ports, 25GB graphics card, eternet connection for PACS interface with graphical user interface for surgical planning, pre-operative navigation and frameless streotaxy.
Catalog Number
ROSAS00369
Brand Name
ROSA PLANNING STATION
Version/Model Number
DELL 7520
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 18, 2019
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
-
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
12af3634-cf45-4096-9141-72c4c1c10c7b
Public Version Date
October 02, 2020
Public Version Number
4
DI Record Publish Date
April 25, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 251 |