| Brand Name | SITE-RITE 8 ULTRASOUND CLASS II SCANNER |
|---|
| Type of Device | TRANSDUCER, ULTRASONIC, DIAGNOSTIC |
|---|
| Manufacturer (Section D) |
| C.R. BARD, INC. (BASD) -3006260740 |
| 605 north 5600 west |
| salt lake city 84116 |
|
|---|
| Manufacturer (Section G) |
| DYMAX CORP. -2523003 |
| 110 marshall drive |
|
| warrendale PA 15086 |
|
|---|
| Manufacturer Contact |
|
shelly
gilbert
|
| 605 north 5600 west |
| salt lake city 84116
|
|
8015950700
|
|
|---|
| MDR Report Key | 11386120 |
|---|
| MDR Text Key | 238415099 |
|---|
| Report Number | 3006260740-2021-00511 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code |
ITX
|
| UDI-Device Identifier | 00801741091032 |
|---|
| UDI-Public | (01)00801741091032 |
|---|
| Combination Product (y/n) | N |
|---|
| Reporter Country Code | BR |
|---|
| PMA/PMN Number | K052517 |
|---|
| Number of Events Reported | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Report Source |
Manufacturer
|
|---|
| Source Type |
company representative,other |
|---|
| Reporter Occupation |
Other Health Care Professional
|
|---|
| Type of Report
| Initial |
|---|
| Report Date |
02/06/2021 |
|---|
| 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? |
Yes
|
|---|
| Device Operator |
Health Professional
|
|---|
| Device Catalogue Number | 9763000 |
|---|
| Was Device Available for Evaluation? |
No
|
|---|
| Is the Reporter a Health Professional? |
Yes
|
|---|
| Initial Date Manufacturer Received |
02/03/2021
|
|---|
| Initial Date FDA Received | 02/26/2021 |
|---|
| 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 |
Reuse
|
|---|
| Patient Sequence Number | 1 |
|---|
| Patient Outcome(s) |
Other;
|
