Brand Name | REST ASSURED, GEN II |
Type of Device | MOUTH GUARD |
Manufacturer (Section D) |
RANIR, LLC |
4701 east paris avenue se |
grand rapids MI 49512 |
|
Manufacturer (Section G) |
RANIR, LLC |
4701 east paris avenue se |
|
grand rapids MI 49512 |
|
Manufacturer Contact |
elsa
baker
|
4701 east paris avenue se |
grand rapids, MI 49512
|
6166988880
|
|
MDR Report Key | 4155978 |
MDR Text Key | 4765346 |
Report Number | 1825660-2014-00927 |
Device Sequence Number | 1 |
Product Code |
OBR
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K091792 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/09/2014 |
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 |
Dentist
|
Device Model Number | REST ASSURED, GEN II |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/11/2014
|
Initial Date FDA Received | 10/09/2014 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|