Brand Name | PATHROMTIN SL |
Type of Device | PATHROMTIN SL |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
emil von behring strasse 76 |
marburg, D-350 41 |
GM D-35041 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
emil von behring strasse 76 |
|
marburg, D-350 41 |
GM
D-35041
|
|
Manufacturer Contact |
james
morgera
|
glasgow business community |
500 gbc drive po box 6101 |
newark, DE 19714-6101
|
3026318356
|
|
MDR Report Key | 6394499 |
MDR Text Key | 69564130 |
Report Number | 9610806-2017-00032 |
Device Sequence Number | 1 |
Product Code |
GFO
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K955450 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
03/10/2017 |
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 Expiration Date | 01/31/2018 |
Device Catalogue Number | OQGS355 SMN 10446067 |
Device Lot Number | 536690B |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/08/2017 |
Initial Date FDA Received | 03/10/2017 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 06/14/2016 |
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 |
|
|