Duns Number:314546664
Device Description: The Fraxion™ Thermoplastic Mask Single Layer (10pcs) is affixed to the Fraxion Headrest as The Fraxion™ Thermoplastic Mask Single Layer (10pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-) positioning. It is used in combination with the Fraxion Vacuum Cushion or Fraxion Vacuum Cushion Plus and the Fraxion Spacer.
Catalog Number
-
Brand Name
Fraxion™
Version/Model Number
P10106-302
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
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
K112210,K112210
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
cefbeda1-f92a-49d6-a5d8-30f539457105
Public Version Date
October 13, 2021
Public Version Number
3
DI Record Publish Date
October 29, 2018
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 |