Brand Name | NUCLEUS-X CATHETER |
Type of Device | AORTIC VALVULOPLASTY CATHETER |
Manufacturer (Section D) |
NUMED, INC. |
2880 main street |
hopkinton NY 12965 |
|
Manufacturer (Section G) |
NUMED, INC. |
2880 main street |
|
hopkinton NY 12965 |
|
Manufacturer Contact |
nichelle
laflesh
|
2880 main street |
hopkinton, NY 12965
|
3153284491
|
|
MDR Report Key | 17737376 |
MDR Text Key | 323290725 |
Report Number | 1318694-2023-00008 |
Device Sequence Number | 1 |
Product Code |
OZT
|
UDI-Device Identifier | 04046964340024 |
UDI-Public | 04046964340024 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K082776 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
09/13/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/13/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 230X |
Device Catalogue Number | PVN403 |
Device Lot Number | NX-2337 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/29/2023 |
Date Manufacturer Received | 08/23/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/21/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |