Brand Name | COATED VICRYL (POLYGLACTIN 910) SUTURE |
Type of Device | SUTURE, ABSORBABLE |
Baseline Brand Name | COATED VICRYL (POLYGLACTIN 910) SUTURE |
Baseline Generic Name | ABSORBABLE SUTURE |
Baseline Catalogue Number | J527H |
Baseline Device Family | COATED VICRYL (POLYGLACTIN 910) SUTURE |
Baseline Device 510(K) Number | K946271 |
Baseline Device PMA Number | |
Baseline Shelf Life Information |
Yes
|
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | 60 |
Date First Marketed | 01/01/1980 |
Manufacturer (Section F) |
ETHICON, INC. SAN ANGELO |
3348 pulliam st. |
san angelo TX 76905 4403 |
|
Manufacturer (Section D) |
ETHICON, INC. SAN ANGELO |
3348 pulliam st. |
san angelo TX 76905 4403 |
|
Manufacturer (Section G) |
ETHICON, INC. |
route 22 west |
|
somerville NJ 08876 0151 |
|
Manufacturer Contact |
georgine
pinel
|
route 22 west |
somerville
, NJ 08876-0151 |
(908)
218
-3486
|
|
Device Event Key | 213264 |
MDR Report Key | 219903 |
Event Key | 206333 |
Report Number | 2210968-1999-00229 |
Device Sequence Number | 1 |
Product Code | GAM |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative
|
Reporter Occupation |
RISK MANAGER
|
Type of Report
| Initial |
Report Date |
03/29/1999 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 04/21/1999 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device EXPIRATION Date | 01/31/2003 |
Device Catalogue Number | J527H |
Device LOT Number | LD8084 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 03/29/1999 |
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 03/01/1999 |
Device Age | 1 yr |
Event Location |
Hospital
|
Date Manufacturer Received | 03/29/1999 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 04/01/1998 |
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|