Duns Number:332599307
Device Description: KermaX Product family is designed to be installed in diagnostic x-ray units and is intende KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
Catalog Number
120-131 AIR
Brand Name
KermaX-plus
Version/Model Number
1
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)
-
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
d53f04b9-d894-4b4a-83bf-60bd0ba6e289
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
December 17, 2021
Package DI Number
EIBA120131AIR1
Quantity per Package
1
Contains DI Package
EIBA120131AIR0
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |