Bortezomib
Bortezomib
SHILPA
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1000274611 | 1000274611 | Shilpa Gampa | 1 | N | 2026-01-01 | 777 Scudders Mill Road, Building 2, Suite 150 Plainsboro NJ US 08536 |
| 3002806503 | 3002806503 | Shilpa Gampa | 1 | N | 2026-01-01 | 777 Scudders Mill Road, Building 2, Suite 150 Plainsboro NJ US 08536 |
| 3016181563 | 3016181563 | Shilpa Gampa | 1 | N | 2026-01-01 | 777 Scudders Mill Road, Building 2, Suite 150 Plainsboro NJ US 08536 |
| 3027502350 | 3027502350 | Shilpa Gampa | 1 | N | 2026-01-01 | 777 Scudders Mill Road, Building 2, Suite 150 Plainsboro NJ US 08536 |
| 3042989730 | 3042989730 | Shilpa Gampa | 1 | N | 2026-01-01 | 777 Scudders Mill Road, Building 2, Suite 150 Plainsboro NJ US 08536 |
| 3043617526 | 3043617526 | Shilpa Gampa | 1 | N | 2026-01-01 | 777 Scudders Mill Road, Building 2, Suite 150 Plainsboro NJ US 08536 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 60678 | 1355105123 | K913185 | STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT | GAQ | 1991-12-04 |
| 60678 | 1680394372 | K911354 | STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES | GAL | 1991-10-25 |
| 60678 | 1388386795 | K911189 | STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE | GAW | 1991-04-25 |
| 60678 | 1899167424 | K905287 | IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES | GAP | 1991-02-11 |
| 60678 | 2057746683 | K905286 | IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES | GAR | 1991-02-11 |
| 60678 | 1247145050 | K905285 | IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES | GAS | 1991-02-11 |
| 235993 | 1890335036 | K193367 | elysion-pro | GEX | 2020-03-12 |
| 235993 | 1141742805 | K191321 | Primelase Excellence | GEX | 2019-08-02 |
| 60678 | 1735809522 | K072863 | ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES | GAM | 2008-05-23 |
| 60678 | 1880926043 | K072859 | ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES | GAM | 2008-05-23 |
| 60678 | 1981929790 | K041048 | POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE | NEW | 2004-06-04 |
| 60678 | 1629535027 | K040282 | ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID | GAM | 2004-04-29 |
| 318417 | 1797949929 | DEN220065 | Pill Sense System | QUD | 2023-02-24 |
| 197356 | 1437538199 | ||||
| 235993 | 1141742805 | ||||
| 346729 | 1240997637 | ||||
| 348322 | 1302309096 | ||||
| 235993 | 1719081140 | ||||
| 235993 | 1881203349 | ||||
| 235993 | 1890335036 |