Duns Number:314546664
Device Description: The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate pa The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate patient repositioning. Each cushion will be moulded individually for each patient and will be stored together with all patient-specific parts in the storage box for the whole treatment time.
Catalog Number
P10106-214
Brand Name
Fraxion
Version/Model Number
P10106-214
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
K112210
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
09e7e993-7563-4fd8-92d8-1fb60014ac08
Public Version Date
October 13, 2021
Public Version Number
5
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 |