Duns Number:264502977
Device Description: "INSTRUMENT HOLDER (V3)instrument Rosa One 3.1 (brain application)Mechanical instrument ho "INSTRUMENT HOLDER (V3)instrument Rosa One 3.1 (brain application)Mechanical instrument holder for accurate mechanical guidance of neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode) positionned by robot arm in accordance with a pre-operative plan."
Catalog Number
ROSAS00498
Brand Name
INSTRUMENT HOLDER (V3)
Version/Model Number
174113-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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,K200511
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
92f0c90e-7e16-430e-87e4-7041ef772804
Public Version Date
October 02, 2020
Public Version Number
3
DI Record Publish Date
June 02, 2020
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 |