| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00616258005096 | 111304-001 | 111304 | DISTA FLEX, FG PKG | MCX | Catheter, Coronary, Atherectomy | 3 | DISTAFLEX |
| 2 | 00616258005089 | 111303-001 | 111303 | SOLENT DISTA, FG PKG | DXE | Catheter, Embolectomy | 2 | SOLENT DISTA |
| 3 | 00616258003849 | 105042-001 | 105042 | XVG CUS CATHETER, FG PKG | DXE | Catheter, Embolectomy | 2 | XVG |
| 4 | 00616258005164 | 011525-001 | 011525 | JETSTREAM GUIDEWIRE | DQX | Wire, Guide, Catheter | JETWIRE | |
| 5 | 00616258003955 | 109400-001 | 109400 | F2 CATHETER FG PKG | DXE | Catheter, Embolectomy | 2 | FETCH 2 |
| 6 | 00616258003887 | 106553-001 | 106553 | SPIROFLEX CUS CATH, FG PKG | DXE | Catheter, Embolectomy | 2 | SPIROFLEX |
| 7 | 00616258003856 | 106608-001 | 106608 | SPIROFLEX VG CUS CATH FG PKG | DXE | Catheter, Embolectomy | 2 | SPIROFLEX VG |
| 8 | 00616258005157 | 112266-001 | 112266 | JETSTREAM XC 2.4MM, FG PKG | MCW | Catheter, Peripheral, Atherectomy | 2 | JETSTREAM XC |
| 9 | 00616258005140 | 112264-001 | 112264 | JETSTREAM XC 2.1 MM, FG PKG | MCW | Catheter, Peripheral, Atherectomy | 2 | JETSTREAM XC |
| 10 | 00616258005102 | 104834-002 | 104834 | PPS ANCILLARY PACK, FG PKG | KRA | Catheter, Continuous Flush | POWER PULSE | |
| 11 | 00616258005133 | 112262-001 | 112262 | JETSTREAM SC 1.85MM, FG PKG | MCW | Catheter, Peripheral, Atherectomy | 2 | JETSTREAM SC |
| 12 | 00616258005126 | 112260-001 | 112260 | JETSTREAM SC 1.6MM, FG PKG | MCW | Catheter, Peripheral, Atherectomy | 2 | JETSTREAM SC |
| 13 | 00616258003894 | 105041-001 | 105041 | XMI CUS CATHETER, FG PKG | DXE | Catheter, Embolectomy | 2 | XMI |
| 14 | 00616258003924 | 109681-001 | 109681 | SOLENT OMNI CATHETER, FG PKG | KRA,DXE | Catheter, Continuous Flush,Catheter, Embolectomy | 2 | SOLENT OMNI |
| 15 | 00616258003900 | 105650-001 | 105650 | ULTRA SYSTEM CONSOLE, FG | MCX | Catheter, Coronary, Atherectomy | 3 | ANGIOJET |
| 16 | 00616258005119 | 050599-001 | 050599 | JETSTREAM CONSOLE | MCW | Catheter, Peripheral, Atherectomy | 2 | JETSTREAM |
| 17 | 00616258003917 | 109676-001 | 109676 | SOLENT PROXI CATH, FG PKG | KRA,DXE | Catheter, Continuous Flush,Catheter, Embolectomy | 2 | SOLENT PROXI |
| 18 | 20888853003058 | ESS305 (Kit) | Essure is a permanent Birth Control System. Each Essure Kit is comprised of two Essure is a permanent Birth Control System. Each Essure Kit is comprised of two pouched disposable delivery systems with a wound-down insert and a valved introducer. | HHS | Insert, Tubal Occlusion | 3 | Essure | |
| 19 | 10888853003051 | ESS305 | Essure is a permanent Birth Control System. One Essure pouched disposable deliv Essure is a permanent Birth Control System. One Essure pouched disposable delivery system with a wound-down insert and a valved introducer. Two Pouched Delivery Systems are contained in the Essure Kit and are not sold separately. | HHS | Insert, Tubal Occlusion | 3 | Essure | |
| 20 | 00888853030517 | ESS305-R1 | Essure is a permanent Birth Control System. One Essure Replacement Kit containi Essure is a permanent Birth Control System. One Essure Replacement Kit containing one pouched disposable delivery system with a wound-down insert and a valved introducer. | HHS | Insert, Tubal Occlusion | 3 | Essure |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B729ICH7FR0 | ICH7FR | The ICHOR embolectomy system is indicated for the non-surgical removal of emboli The ICHOR embolectomy system is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The device is intended for the peripheral vasculature. | ICHOR | ICHOR VASCULAR, INC. | |
| 2 | B380NL7FEMB80T0 | NL7FEMB80T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 3 | B380NL7FEMB800 | NL7FEMB80 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 4 | B380NL7FEMB40T0 | NL7FEMB40T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 5 | B380NL7FEMB400 | NL7FEMB40 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 6 | B380NL7EMB80T0 | NL7EMB80T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 7 | B380NL7EMB800 | NL7EMB80 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 8 | B380NL7EMB40T0 | NL7EMB40T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 9 | B380NL7EMB400 | NL7EMB40 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 10 | B380NL6FEMB80T0 | NL6FEMB80T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 11 | B380NL6FEMB800 | NL6FEMB80 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 12 | B380NL6FEMB40T0 | NL6FEMB40T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 13 | B380NL6FEMB400 | NL6FEMB40 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 14 | B380NL6EMB80T0 | NL6EMB80T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 15 | B380NL6EMB800 | NL6EMB80 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 16 | B380NL6EMB40T0 | NL6EMB40T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 17 | B380NL6EMB400 | NL6EMB40 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 18 | B380NL5FEMB80T0 | NL5FEMB80T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 19 | B380NL5FEMB800 | NL5FEMB80 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 20 | B380NL5FEMB40T0 | NL5FEMB40T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 21 | B380NL5FEMB400 | NL5FEMB40 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 22 | B380NL5EMB80T0 | NL5EMB80T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 23 | B380NL5EMB800 | NL5EMB80 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 24 | B380NL5EMB40T0 | NL5EMB40T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 25 | B380NL5EMB400 | NL5EMB40 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 26 | B380NL4FEMB80T0 | NL4FEMB80T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 27 | B380NL4FEMB800 | NL4FEMB80 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 28 | B380NL4FEMB40T0 | NL4FEMB40T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 29 | B380NL4FEMB400 | NL4FEMB40 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 30 | B380NL4FEMB1000 | NL4FEMB100 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 31 | B380NL4EMB80T0 | NL4EMB80T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 32 | B380NL4EMB800 | NL4EMB80 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 33 | B380NL4EMB40T0 | NL4EMB40T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 34 | B380NL4EMB400 | NL4EMB40 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 35 | B380NL4EMB1000 | NL4EMB100 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 36 | B380NL3FEMB80T0 | NL3FEMB80T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 37 | B380NL3FEMB800 | NL3FEMB80 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 38 | B380NL3FEMB40T0 | NL3FEMB40T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 39 | B380NL3FEMB400 | NL3FEMB40 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 40 | B380NL3EMB80T0 | NL3EMB80T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 41 | B380NL3EMB800 | NL3EMB80 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 42 | B380NL3EMB40T0 | NL3EMB40T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 43 | B380NL3EMB400 | NL3EMB40 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 44 | B380NL2FEMB60T0 | NL2FEMB60T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 45 | B380NL2FEMB600 | NL2FEMB60 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 46 | B380NL2FEMB40T0 | NL2FEMB40T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 47 | B380NL2FEMB400 | NL2FEMB40 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 48 | B380NL2EMB60T0 | NL2EMB60T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 49 | B380NL2EMB600 | NL2EMB60 | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC | ||
| 50 | B380NL2EMB40T0 | NL2EMB40T | LMI ARTERIAL EMBOLECTOMY CATHETER | LUCAS MEDICAL INC |