Brand Name | CUSA EXCEL 36KHZ STRAIGHT HANDPIECE |
Type of Device | ULTRASONIC SURGICAL PRODUCTS |
Manufacturer (Section D) |
INTEGRA LIFESCIENCES(IRELAND) |
ida business&technology park |
ida business&technology park |
sragh, tullamore, co.offaly |
EI |
|
Manufacturer (Section G) |
INTEGRA LIFESCIENCES(IRELAND) |
ida business&technology park |
|
sragh, tullamore, co.offaly |
EI
|
|
Manufacturer Contact |
vivian
nelson
|
1000 campus drive |
princeton, NJ 08536
|
6099362319
|
|
MDR Report Key | 10280617 |
MDR Text Key | 204769808 |
Report Number | 3006697299-2019-00152 |
Device Sequence Number | 1 |
Product Code |
LFL
|
Combination Product (y/n) | N |
PMA/PMN Number | K141674 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/17/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/15/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | C2602 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 11/17/2019 |
Date Device Manufactured | 03/01/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|