Duns Number:332599307
Device Description: Single channel dosimeter according to IEC 61674, designed for acceptance tests and for qua Single channel dosimeter according to IEC 61674, designed for acceptance tests and for quality checks at radiographic, fluoroscopic, dental and mammographic X-ray units.
Catalog Number
VD0201747
Brand Name
Dosimeter Dosimax plus A
Version/Model Number
VD0201747
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
3cdd8ea0-64bd-4e3f-a523-b56942bacf88
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 |