Brand Name | OPMI LUMERA T |
Type of Device | OPMI LUMERA T |
Manufacturer (Section D) |
CARL ZEISS MEDITEC AG (OBERKOCHEN) |
rudolf-eber-strasse 11 |
oberkochen, 73447 |
GM 73447 |
|
Manufacturer (Section G) |
CARL ZEISS MEDITEC AG (OBERKOCHEN) |
rudolf-eber-strasse 11 |
|
oberkochen, 73447 |
GM
73447
|
|
Manufacturer Contact |
vernon
brown
|
5160 hacienda drive |
dublin, CA 94568
|
9255574689
|
|
MDR Report Key | 8725076 |
MDR Text Key | 166591069 |
Report Number | 9615010-2019-00004 |
Device Sequence Number | 1 |
Product Code |
HRM
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | N/A |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
05/24/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/21/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 302608-9020-000 |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 05/24/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/30/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
|
|