Duns Number:314546664
Device Description: The FRAXION™ Mouthpiece is affixed to the Fraxion Frontpiece assuring safe immobilization The FRAXION™ Mouthpiece is affixed to the Fraxion Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum.
Catalog Number
P10106-320
Brand Name
Fraxion
Version/Model Number
P10106-320
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
0b36f5fb-f598-4bf2-b504-77fc807f1502
Public Version Date
October 13, 2021
Public Version Number
5
DI Record Publish Date
August 23, 2016
Package DI Number
04056719001582
Quantity per Package
10
Contains DI Package
04056719001759
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |