| Brand Name | SONOPET IQ ULTRASONIC ASPIRATOR CONSOLE |
|---|
| Type of Device | INSTRUMENT, ULTRASONIC SURGICAL |
|---|
| Manufacturer (Section D) |
| STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP |
| 1941 stryker way |
| portage MI 49002 |
|
|---|
| Manufacturer (Section G) |
| STRYKER INSTRUMENTS-KALAMAZOO |
| 4100 east milham avenue |
|
| kalamazoo MI 49001 |
|
|---|
| Manufacturer Contact |
|
zach
baker
|
| 1941 stryker way |
| portage, MI 49002
|
|
2693237700
|
|
|---|
| MDR Report Key | 11555648 |
|---|
| MDR Text Key | 242229372 |
|---|
| Report Number | 3015967359-2021-00242 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code |
LFL
|
| UDI-Device Identifier | 07613327364675 |
|---|
| UDI-Public | 07613327364675 |
|---|
| Combination Product (y/n) | N |
|---|
| Reporter Country Code | US |
|---|
| PMA/PMN Number | K190070 |
|---|
| Number of Events Reported | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Report Source |
Manufacturer
|
|---|
| Source Type |
company representative |
|---|
| Reporter Occupation |
Other
|
|---|
| Type of Report
| Initial |
|---|
| Report Date |
03/23/2021 |
|---|
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Date FDA Received | 03/23/2021 |
|---|
| Is this an Adverse Event Report? |
No
|
|---|
| Is this a Product Problem Report? |
Yes
|
|---|
| Device Operator |
Other
|
|---|
| Device Model Number | 5500050000 |
|---|
| Device Catalogue Number | 5500050000 |
|---|
| Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
|---|
| Date Returned to Manufacturer | 02/12/2021 |
|---|
| Date Manufacturer Received | 02/23/2021 |
|---|
| Was Device Evaluated by Manufacturer? |
Yes
|
|---|
| Date Device Manufactured | 01/13/2020 |
|---|
| Is the Device Single Use? |
No
|
|---|
| Is This a Reprocessed and Reused Single-Use Device? |
No
|
|---|
| Type of Device Usage |
Reuse
|
|---|
| Patient Sequence Number | 1 |
|---|
