Duns Number:264502977
Device Description: Leksell Registration Platesinstrument Rosa One 3.1 (brain application)Leksell frame regsit Leksell Registration Platesinstrument Rosa One 3.1 (brain application)Leksell frame regsitration plates : calibrated tool for manual regsitration of the device with the leksell frame. Mounted on the leksell stereotactic frame.
Catalog Number
ROSAS00500
Brand Name
LEKSELL FRAME REGISTRATION PLATES
Version/Model Number
174016-01
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
K200511
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
162c4f41-a4d5-46d5-aa32-c77236a2a059
Public Version Date
July 12, 2022
Public Version Number
2
DI Record Publish Date
October 20, 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 |