Brand Name | NEOTECH PRODUCTS LLC |
Type of Device | RADIOLUCENT NEOLEADS |
Manufacturer (Section D) |
NEOTECH PRODUCTS LLC |
28430 witherspoon parkway |
valencia 91355 |
|
Manufacturer (Section G) |
NEOTECH PRODUCTS LLC |
28430 witherspoon pkw |
|
valencia CA 91355 |
|
Manufacturer Contact |
ben
mahajan
|
28430 witherspoon parkway |
valencia, CA 91355
|
6617757466
|
|
MDR Report Key | 7542305 |
MDR Text Key | 109187750 |
Report Number | 2025917-2018-00106 |
Device Sequence Number | 1 |
Product Code |
DRX
|
UDI-Device Identifier | 00812594010293 |
UDI-Public | 00812594010293 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K011564 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Health Professional
|
Remedial Action |
Inspection |
Type of Report
| Initial |
Report Date |
05/24/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/01/2019 |
Device Model Number | N305 |
Device Catalogue Number | N305 |
Device Lot Number | 2017-9012 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/26/2018 |
Initial Date FDA Received | 05/24/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/01/2017 |
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 |
Patient Outcome(s) |
Other;
|
Patient Age | 14 DA |
Patient Weight | 2 |