Brand Name | DENTAPURE DP365 CARTRIDGE |
Type of Device | DENTAL UNIT WATERLINE PURIFICATION CARTRIDGE |
Manufacturer (Section D) |
CROSSTEX INTERNATIONAL INC. |
10 ranick road |
hauppauge NY 11788 |
|
Manufacturer (Section G) |
CROSSTEX INTERNATIONAL INC. |
10 ranick road |
|
hauppauge NY 11788 |
|
Manufacturer Contact |
sadie
martin
|
10 ranick road |
hauppauge, NY 11788
|
7632487189
|
|
MDR Report Key | 7772929 |
MDR Text Key | 116774005 |
Report Number | 2433773-2018-00002 |
Device Sequence Number | 1 |
Product Code |
EIA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K992893 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
08/10/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/10/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | DP365B |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/11/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|