Brand Name | AIA-360 |
Type of Device | AIA-360 |
Manufacturer (Section D) |
TOSOH BIOSCIENCE, INC. |
3600 gantz road |
grove city, oh |
|
Manufacturer (Section G) |
TOSOH BIOSCIENCE, INC. |
3600 gantz road |
|
grove city, oh |
|
Manufacturer Contact |
bernadette
oconnell
|
6000 shoreline court |
suite 101 |
south san francisco, ca
|
9368143
|
|
MDR Report Key | 9958211 |
MDR Text Key | 261266058 |
Report Number | 3005529799-2020-00032 |
Device Sequence Number | 1 |
Product Code |
KHO
|
Combination Product (y/n) | N |
Reporter Country Code | PM |
PMA/PMN Number | K971103 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/10/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/14/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | AIA-360 |
Device Catalogue Number | 019945 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/19/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/15/2016 |
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 |
|
|