Device product
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.
Z-0510-2019
Product summary
- Firm
- Numed Inc
- Event
- Event 81460
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-0510-2019
Official wording
Reason: Instructions for Use booklets were not included on the outer pouch
Code information: Lot numbers: 5MT-1264, 5MT-1265 Exp. Date: 2023-09-30 UDI: 04046964312700
Distribution pattern: US distribution in the state of PA
Derived failure modes
-
Unknown
Instructions for Use booklets were not included on the outer pouch