Duns Number:264502977
Device Description: 2D X-Ray Leksell Frame Platesinstrument Rosa One 3.1 (brain application)calibrated tool fo 2D X-Ray Leksell Frame Platesinstrument Rosa One 3.1 (brain application)calibrated tool for manual registration of the device with the Leksell frame. Mounted on the Leksell stereotactic frame."
Catalog Number
ROSAS00345
Brand Name
2D X-RAY LEKSELL FRAME REGST PLATES
Version/Model Number
174015
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
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
c1d8d418-9d48-4fa3-b4bf-e36ec732cd38
Public Version Date
July 12, 2022
Public Version Number
3
DI Record Publish Date
July 27, 2019
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 |