Brand Name | CERTAS INLIN VLV ONLY W/SPHNGD |
Type of Device | CERTAS PLUS W/ SG |
Manufacturer (Section D) |
INTEGRA LIFESCIENCES SWITZERLAND SAR |
rue girardet 29 |
rue girardet 29 |
le locle |
SZ
|
|
Manufacturer (Section G) |
INTEGRA LIFESCIENCES SWITZERLAND SAR |
rue girardet 29 |
ch-2400 |
le locle |
SZ
|
|
Manufacturer Contact |
vivian
nelson
|
1100 campus drive |
princeton, NJ
|
6099362319
|
|
MDR Report Key | 13077345 |
MDR Text Key | 282711263 |
Report Number | 3013886523-2021-00564 |
Device Sequence Number | 1 |
Product Code |
JXG
|
Combination Product (y/n) | N |
PMA/PMN Number | K143111 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
02/09/2022 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 12/23/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
No
|
Device Operator |
|
Device Catalogue Number | 828804 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/18/2022 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/25/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unkown
|