Duns Number:108179458
Device Description: Unibody™ Bone Fiducials (13mm) for use with the Nexframe® Sterotactic System
Catalog Number
FM-4013
Brand Name
Unibody™ Bone Fiducials (13mm)
Version/Model Number
FM-4013-00857
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
Yes
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
K033619,K033619
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
4da6f00b-824e-45b9-92c2-b788ffeb0fb0
Public Version Date
May 26, 2022
Public Version Number
1
DI Record Publish Date
May 18, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |