Duns Number:264502977
Device Description: OPTICAL DISTANCE SENSOR (V3)instrument Rosa 3.0Instrument ROSA One 3.1Optical distance sen OPTICAL DISTANCE SENSOR (V3)instrument Rosa 3.0Instrument ROSA One 3.1Optical distance sensor for contactless location of anatomical structures or landmarks. Used for markerless automatic registration and free-hand navigation
Catalog Number
ROSAS00316
Brand Name
OPTICAL DISTANCE SENSOR
Version/Model Number
ROSA3-277B
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,K172444,K182417,K200511
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
6e8fc4d6-d63c-431e-a5b9-f5caf682a78e
Public Version Date
October 02, 2020
Public Version Number
6
DI Record Publish Date
October 09, 2016
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 |