Duns Number:312623008
Device Description: The Navigation sensor Mayfield is a product variant of a navigation sensor which is mounta The Navigation sensor Mayfield is a product variant of a navigation sensor which is mountable to a ‘Carbon Skull clamp’ set consisting of the third party product Integra Mayfield Infinity XR2 Skull Clamp (A2114) mounted to the OR table using the third party product Integra Mayfield Ultra Base Unit (A-2101) and is referred to as ‘base unit’ below. The navigation sensor Mayfield is to be mounted to the Carbon Skull clamp, to create an electromagnetic field in the surgical area. It will enable the usage of the fiagon navigation system during neurological surgeries.
Catalog Number
-
Brand Name
Navigation Sensor Mayfield
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K151156
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
6da105a5-5d74-4cfa-8d70-23e0048b2afd
Public Version Date
October 25, 2022
Public Version Number
5
DI Record Publish Date
August 10, 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 |
|---|---|---|
| 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. | 18 |