Device product
RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the skin of the patient to help the user place the needles in a grid pattern. The letters and numbers can also correspond with computerized grids to aid in placement.
Z-0777-2019
Product summary
- Event
- Event 81935
- Status
- Terminated
- Classification
- Class III
- Quantity
- 443 devices
- Official record key
device-enforcement:Z-0777-2019
Official wording
Reason: Product is labeled with "CE", but is not yet approved in the European Union.
Code information: Lot Numbers: 18061816, 18101521
Distribution pattern: US Nationwide Distribution in the states of IL, WA, and FL
Derived failure modes
-
Unknown
Product is labeled with "CE", but is not yet approved in the European Union.