Brand Name | INTRACEPT ACCESS INSTRUMENTS |
Type of Device | PROBE, RADIOFREQUENCY LESION AND ACCESSORIES |
Manufacturer (Section D) |
RELIEVANT MEDSYSTEMS, INC. |
1230 midas way |
suite 200 |
sunnyvale CA 94085 4068 |
|
Manufacturer Contact |
thomas
slater
|
1230 midas way |
suite 200 |
sunnyvale, CA 94085-4068
|
6503681000
|
|
MDR Report Key | 14740032 |
MDR Text Key | 294877152 |
Report Number | 3006789852-2022-00003 |
Device Sequence Number | 1 |
Product Code |
GXI
|
UDI-Device Identifier | 00852454006189 |
UDI-Public | (01)00852454006189(17)230702(10)127318321 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K213836 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/25/2022 |
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 | 07/02/2023 |
Device Model Number | FG 0060 |
Device Catalogue Number | RLV AK05 |
Device Lot Number | 127318231 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/25/2022 |
Initial Date FDA Received | 06/18/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/02/2021 |
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) |
Required Intervention;
Disability;
|
Patient Age | 87 YR |