Duns Number:314546664
Device Description: The FRAXION™ Patient Control Unit (PCU) provides the vacuum necessary for securing the mou The FRAXION™ Patient Control Unit (PCU) provides the vacuum necessary for securing the mouthpiece to the patient’s maxilla, thus securely immobilizing the patient. It monitors the vacuum level to the mouthpiece and provides an alert when the mouthpiece becomes loosened. Additionally, the PCU is used for forming the vacuum cushion.
Catalog Number
P10106-102
Brand Name
Fraxion
Version/Model Number
P10106-102
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
-
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
cce8c39b-38b6-4bd2-aa8c-9a07ba0c7984
Public Version Date
August 12, 2019
Public Version Number
4
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 |