CT Syringe For Stellant Injectors (with & Without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack For Stellant Injectors (with & Without Spikes, Prime Tubes, & Fill Tubes), Single Fascia And Ram Tip, Dual Fascia And Ram Tip
Coeur, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1038185 | 1038185 | COEUR, INC.(A WHOLLY OWNED SUBSIDIARY OF ILLINOIS TOOL WORKS INC.) | 1 | N | 2026-01-01 | 209 Creekside Dr WASHINGTON NC US 27889 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| M297100600 | Coeur - 60 in. Coiled Line | 1-800-296-5893 | customer.service@coeurinc.com |
| M297100610 | Coeur - 60 in. Coiled Line with 1 Check Valve | 1-800-296-5893 | customer.service@coeurinc.com |
| M297101230 | Coeur - 4 in Extension Line with Check Valve and Male Luer with Rotating Skirt | 1-800-296-5893 | customer.service@coeurinc.com |
| M297722010 | Coeur - "MR Syringe Dual Pack for Spectris Solaris Injectors (Includes; 1-65mL Syringe, 1-115mL Syringe, 1-96"" Y-Line, and 2 Spikes)" | 1-800-296-5893 | customer.service@coeurinc.com |
| M297722070 | Coeur - "MR Syringe Dual Pack for Spectris Solaris Injectors (Includes; 2-65mL Syringes, 1-96"" Y-Line and 2 Spikes)" | 1-800-296-5893 | customer.service@coeurinc.com |
| M297731020 | Coeur - " 200mL Single Syringe Kit for Stellant Injectors (Includes 1-200mL Syringes, 1-60"" Y-line, and 1 Spike" | 1-800-296-5893 | customerservice@coeurinc.com |
| M297732010 | Coeur - "200mL Dual-Syringe Kit for Stellant Injectors (Includes 2-200mL Syringes, 1-60"" Y-line, and 2-Spikes" | 1-800-296-5893 | customer.service@coeurinc.com |
| M297732020 | Coeur - "200mL Dual-Syringe Kit for Stellant Injectors (Includes 2-200mL Syringes, 1-60"" Y-line, 1 Contrast Spike, and 1-Saline Spike" | 1-800-296-5893 | customer.service@coeurinc.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 56550 | 1704564906 | K971712 | COEUR 130 ML ANGIOGRAPHIC SYRINGE | DXT | 1997-10-08 |
| 56550 | 1278311411 | K960965 | FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 | DXT | 1996-09-12 |
| 56550 | 1229687065 | K942381 | LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING | DXT | 1995-03-17 |
| 56550 | 1229135635 | K873597 | TUBING, POLYETHYLENE | DXT | 1987-11-12 |
| 56550 | 1285426212 | K823920 | COEURLOCK STERILE DISPOS. ANGIOGRAPHIC | DXT | 1983-02-18 |
| 56550 | 2013284469 | K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip | DXT | 2017-08-18 |
| 56550 | 1217058079 | K161471 | MR Syringe Dual Pack for Solaris Injectors | DXT | 2016-10-06 |
| 56550 | 1362985714 | K150902 | 330psi Extension Y-Line with Dual Check Valve | DXT | 2015-10-22 |
| 56550 | 1076585164 | K142745 | 125mL CT Syringe | DXT | 2015-04-01 |
| 56550 | 1157084037 | K140469 | MR SYRINGE DUAL PACK | DXT | 2014-07-28 |
| 56550 | 1727650839 | K133600 | COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR | DXT | 2014-04-30 |
| 56550 | 1299253651 | K120892 | DISPOSABLE 330PSI EXTENSION LINES | DXT | 2013-06-10 |
| 56550 | 1156844257 | K090487 | DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 | DXT | 2009-10-19 |
| 56550 | 1581237058 | K071196 | DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS | DQO | 2007-09-06 |
| 56550 | 1162585226 | K070798 | ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS | DXT | 2007-10-04 |
| 56550 | 1915196408 | K063114 | DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES | FPK | 2007-02-09 |
| 56550 | 1438128642 | K051799 | DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS | DXT | 2005-11-02 |
| 56550 | 1794649330 | K032920 | THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 | DXT | 2003-12-16 |
| 56550 | 1029127433 | ||||
| 56550 | 1208258038 | ||||
| 56550 | 1561490182 | ||||
| 56550 | 1850870511 |
Coeur, Inc.
Coeur, Inc.
COEUR, INC.
COEUR, INC.
COEUR, INC.
COEUR, INC.
COEUR, INC.
COEUR, INC.
COEUR, INC.
COEUR, INC.
COEUR, INC.
COEUR, INC.
COEUR, INC.
COEUR, INC.
COEUR MEDICAL
COEUR LABORATORIES, INC.
COEUR LABORATORIES, INC.
COEUR LABORATORIES, INC.
COEUR LABORATORIES, INC.
COEUR LABORATORIES, INC.
COEUR LABORATORIES, INC.
COEUR LABORATORIES, INC.
COEUR LABORATORIES, INC.
COEUR LABORATORIES, INC.
COEUR LABORATORIES, INC.
2019-02-11
2019-02-11
2019-02-11
2019-02-11
2019-02-11
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-14
2016-07-15
2016-07-14
2016-07-14
2016-07-14
2016-07-14