| Brand Name | 8592000-SURETRANS A/T W/3/16 |
|---|
| Type of Device | 350101216-SURETRANS |
|---|
| Baseline Brand Name | SURETRANS |
|---|
| Baseline Generic Name | AUTOTRANSFUSION APARATUS |
|---|
| Baseline Catalogue Number | 8592000 |
|---|
| Baseline Device Family | AUTOTRANSFUSION |
|---|
| Baseline Device 510(K) Number | K913247 |
|---|
| Baseline Device PMA Number | |
|---|
| Baseline Preamendment? |
No
|
|---|
| Transitional? |
No
|
|---|
| 510(K) Exempt? |
No
|
|---|
| Shelf Life(Months) | NA |
|---|
| Date First Marketed | 02/01/1996 |
|---|
| Manufacturer (Section F) |
| DAVOL SURGICAL INNOVATIONS (JUAREZ/MX) |
| ave. roberto fierro #6408 |
| parque ind. aeropuerto |
| juarez, chih |
|
MEXICO
32690
|
|
| Manufacturer (Section D) |
| DAVOL SURGICAL INNOVATIONS (JUAREZ/MX) |
| ave. roberto fierro #6408 |
| parque ind. aeropuerto |
| juarez, chih |
|
MEXICO
32690
|
|
| Manufacturer (Section G) |
| DAVOL SURGICAL INNOVATIONS (JUAREZ/MX) |
| ave. roberto fierro #6408 |
| parque ind. aeropuerto |
| juarez, chih |
|
MEXICO
32690
|
|
| Manufacturer Contact |
|
thomas
swanson, sr. coordinator
|
| 100 sockanossett crossroad |
| cranston
, RI 02920 |
| (401)
463
-7000
|
|
| Device Event Key | 462762 |
|---|
| MDR Report Key | 473911 |
|---|
| Event Key | 449202 |
|---|
| Report Number | 1213643-2003-00059 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | CAC |
|---|
| Report Source |
Manufacturer
|
|---|
| Source Type |
Company Representative
|
|---|
| Reporter Occupation |
Nurse
|
| Type of Report
| Initial |
|---|
| Report Date |
07/08/2003 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 07/17/2003 |
|---|
| Is This An Adverse Event Report? |
No
|
|---|
| Is This A Product Problem Report? |
Yes
|
|---|
| Device Operator |
Health Professional
|
| Device Catalogue Number | 8592000 |
|---|
| Device LOT Number | 41ANN080 |
|---|
| Was Device Available For Evaluation? |
No
|
|---|
| Is The Reporter A Health Professional? |
No
|
|---|
| Was the Report Sent to FDA? |
No
|
|---|
| Distributor Facility Aware Date | 07/08/2003 |
|---|
| Event Location |
Hospital
|
| Date Manufacturer Received | 07/08/2003 |
|---|
| Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
|---|
| Date Device Manufactured | 01/01/2003 |
|---|
| Is The Device Single Use? |
Yes
|
|---|
| Is the Device an Implant? |
No
|
|---|
| Is this an Explanted Device? |
No Answer Provided
|
|---|
| Type of Device Usage |
Unkown
|
|---|
