Brand Name | SURGIGUIDE |
Type of Device | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
Manufacturer (Section D) |
DENTSPLY IMPLANTS N.V. |
research campus 10 |
hasselt limburg, B-350 0 |
BE B-3500 |
|
Manufacturer (Section G) |
DENTSPLY IMPLANTS N.V. |
research campus 10 |
|
hasselt limburg, B-350 0 |
BE
B-3500
|
|
Manufacturer Contact |
helen
lewis
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178494229
|
|
MDR Report Key | 5799084 |
MDR Text Key | 49754566 |
Report Number | 3007362683-2016-00007 |
Device Sequence Number | 1 |
Product Code |
LLZ
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K113739 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
06/15/2016 |
3 Devices were Involved in the Event: |
1
2
3
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/15/2016 |
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 37503 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/15/2016 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/15/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/12/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|