Duns Number:264502977
Device Description: LEKSELL FRAME REGISTRATION PLATESinstrument Rosa 3.0instrument Rosa 3.1Leksell frame regsi LEKSELL FRAME REGISTRATION PLATESinstrument Rosa 3.0instrument Rosa 3.1Leksell frame regsitration plates : calibrated tool for manual regsitration of the device with the leksell frame. Mounted on the leksell stereotactic frame.
Catalog Number
ROSAS00347
Brand Name
LEKSELL FRAME REGISTRATION PLATES
Version/Model Number
ROSA3-286A
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
0cf5d9d5-46de-4770-9d9a-71f1ffeb9d40
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 |