Duns Number:268397609
Device Description: The Patient Reference is an instrument of the EPIONE device used to track the patientposit The Patient Reference is an instrument of the EPIONE device used to track the patientposition and motions including breathing.
Catalog Number
02-0026
Brand Name
Patient Reference
Version/Model Number
02-0026
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
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
b5b1a2c6-1b87-4cfe-b45f-5b9d96bd8f45
Public Version Date
September 19, 2022
Public Version Number
1
DI Record Publish Date
September 09, 2022
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. | 5 |