Brand Name | TOSOH HLC-723G8 ANALYZER G8 |
Type of Device | TOSOH HLC-723G8 ANALYZER G8 |
Manufacturer (Section D) |
TOSOH CORPORATION |
shiba-koen first building |
3-8-2 shiba |
minato-ku, tokyo 10586 23 |
JA 1058623 |
|
Manufacturer (Section G) |
TOSOH CORPORATION (MANUFACTURER) |
shiba-koen first building |
3-8-2 shiba |
minato-ku, tokyo 10586 23 |
JA
1058623
|
|
Manufacturer Contact |
doria
esquivel
|
6000 shoreline court |
suite 101 |
south san francisco, CA 94080
|
6506368123
|
|
MDR Report Key | 7387470 |
MDR Text Key | 104252548 |
Report Number | 8031673-2018-03293 |
Device Sequence Number | 1 |
Product Code |
LCP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K071132 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
03/30/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | G8 |
Device Catalogue Number | 021560 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/30/2018 |
Distributor Facility Aware Date | 10/16/2015 |
Device Age | 6 YR |
Event Location |
Outpatient Diagnostic Facility
|
Date Report to Manufacturer | 03/30/2018 |
Initial Date Manufacturer Received |
10/16/2015 |
Initial Date FDA Received | 03/30/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/01/2009 |
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 |