Duns Number:332599307
Device Description: Multimeter MagicMaX Universal PT, developed in accordance with IEC 61674 & IEC 61676. Flex Multimeter MagicMaX Universal PT, developed in accordance with IEC 61674 & IEC 61676. Flexible solution for exact dose- and kV-measurements specialized for kV imager at ProtonTherapy systems.
Catalog Number
DP0202010
Brand Name
Multimeter MagicMaX Universal PT with special calibration
Version/Model Number
DP0202010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
LHO
Product Code Name
Instrument, Quality-Assurance, Radiologic
Public Device Record Key
9cbb5292-bd29-4904-a9a9-7ec92dea5144
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
October 26, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |