Duns Number:314546664
Device Description: A single HeadFIX® Marking Set CRANIAL P2 comprises 3 marking plates for the HeadFIX Local A single HeadFIX® Marking Set CRANIAL P2 comprises 3 marking plates for the HeadFIX Localizers. These plates assist in patient positioning and light field verification.
Catalog Number
P10103-210
Brand Name
HeadFIX
Version/Model Number
P10103-210
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 28, 2020
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
-
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
4f63f779-8cb9-4fcd-888b-bfa31b7630f6
Public Version Date
August 31, 2020
Public Version Number
3
DI Record Publish Date
August 23, 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. | 175 |