Duns Number:264502977
Device Description: RADIOLUCENT SUPPORT ARMinstrument Rosa 3.0instrument Rosa 3.1Radiolucent support arm for r RADIOLUCENT SUPPORT ARMinstrument Rosa 3.0instrument Rosa 3.1Radiolucent support arm for rigid fixation of the robot stand to a neurosurgical head holder (mayfield and PMI DORO) or stereotactic frame (leksell) with adaptors.
Catalog Number
ROSAS00323
Brand Name
RADIOLUCENT SUPPORT ARM
Version/Model Number
ROSA3-175C
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
b78792f1-06d0-43d2-b02c-7a2a319f4463
Public Version Date
October 02, 2020
Public Version Number
7
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 |