Brand Name | GLIDESCOPE AVL VIDEO BATON 3-4 |
Type of Device | VIDEO LARYNGOSCOPE |
Manufacturer (Section D) |
VERATHON MEDICAL ULC |
burnaby, bc |
CA |
|
Manufacturer (Section G) |
VERATHON MEDICAL ULC |
2227 douglas rd |
|
burnaby, bc V5C 5A9 |
CA
V5C 5A9
|
|
Manufacturer Contact |
adam
gaines, sr specialist
|
20001 north creek pkwy |
bothell, WA 98011
|
4256295606
|
|
MDR Report Key | 3723704 |
MDR Text Key | 4330194 |
Report Number | 9615393-2014-00001 |
Device Sequence Number | 1 |
Product Code |
CCW
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Type of Report
| Initial |
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? |
No
|
Device Operator |
Other
|
Initial Date Manufacturer Received |
12/05/2013
|
Initial Date FDA Received | 01/03/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/01/2010 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|