No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | H787MRC3S970 | MRC3S97 | C3 WAVE REMOTE BATTERY ACC | LJS | Catheter, intravascular, therapeutic, long-term greater than 30 days | 2 | C3 WAVE SYSTEM | |
2 | H787MRC3S950 | MRC3S95 | C3 WAVE IPAD CASE ACCESSORY | LJS | Catheter, intravascular, therapeutic, long-term greater than 30 days | 2 | C3 WAVE SYSTEM | |
3 | H787MRC3S940 | MRC3S94 | C3 WAVE QUICK RELEASE CLAMP | LJS | Catheter, intravascular, therapeutic, long-term greater than 30 days | 2 | C3 WAVE SYSTEM | |
4 | H787MRC3S900 | MRC3S90 | C3 WAVE HUB ACCESSORY | LJS | Catheter, intravascular, therapeutic, long-term greater than 30 days | 2 | C3 WAVE SYSTEM | |
5 | H787203001010 | 20300101 | NanoKnife Generator | OAB | Low energy direct current thermal ablation system | 2 | NanoKnife | |
6 | H787117197110 | 11719711 | Mariner Hydrophilic Coated Angiographic Catheter, Cobra (2), Non-Braided | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | Mariner | ||
7 | H965814001240 | 81400124 | Y-ADAPTOR,LG.BORE,FINE THREAD W/10" FLEXCIL EXT.-OEM | DTL | Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass | 2 | NAMIC | |
8 | H965800450750 | 80045075 | NEEDLE GUIDEWIRE INTRODUCER - OEM | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NAMIC | |
9 | H965252000 | 25-200 | AngioVac F18 85 Cannula | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | AngioVac | |
10 | H965251940 | 25194 | AngioVac C180 with Obturator | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | AngioVac | ||
11 | H965251930 | 25193 | AngioVac C20 with Obturator | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | AngioVac | ||
12 | H787128002040 | 12800204 | SpeedLyser Infusion Catheter Basic Kit | QEY | Mechanical thrombolysis catheter | SpeedLyser | ||
13 | H787506002190 | 50600219 | AngiOptic Angiographic Catheter, Cobra (1), Non-Braided | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | AngiOptic | ||
14 | H787506001480 | 50600148 | AngiOptic Angiographic Catheter, Sos Omni Selective (0), Non-Braided | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | AngiOptic | ||
15 | H787506001310 | 50600131 | AngiOptic Angiographic Catheter, Sos Omni Selective (2), Non-Braided | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | AngiOptic | ||
16 | H787506001210 | 50600121 | AngiOptic Angiographic Catheter, Straight Art, Non-Braided | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | AngiOptic | ||
17 | H787128002020 | 12800202 | SpeedLyser Infusion Catheter Basic Kit | QEY | Mechanical thrombolysis catheter | SpeedLyser | ||
18 | H787128002010 | 12800201 | SpeedLyser Infusion Catheter Basic Kit | QEY | Mechanical thrombolysis catheter | SpeedLyser | ||
19 | H787124018640 | 12401864 | Uni-Fuse+ Infusion System 5F, 135cm, 15cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
20 | H787124018630 | 12401863 | Uni-Fuse+ Infusion System 5F, 135cm, 2cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
21 | H787124018620 | 12401862 | Uni-Fuse+ Infusion System 5F, 90cm, 15cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
22 | H787124018610 | 12401861 | Uni-Fuse+ Infusion System 5F, 90cm, 2cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
23 | H787124018600 | 12401860 | Uni-Fuse+ Infusion System 4.3F, 135cm, 15cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
24 | H787124018590 | 12401859 | Uni-Fuse+ Infusion System 4.3F, 135cm, 2cm | KRA | Catheter, continuous flush | Uni-Fuse+ | ||
25 | H787124018580 | 12401858 | Uni-Fuse+ Infusion System 4.3F, 90cm, 15cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
26 | H787124018570 | 12401857 | Uni-Fuse+ Infusion System 4.3F, 90cm, 2cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
27 | H787124018550 | 12401855 | Uni-Fuse+ Infusion System 4.3F, 135cm, 10cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
28 | H787124018540 | 12401854 | Uni-Fuse+ Infusion System 4.3F, 135cm, 5cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
29 | H787124018520 | 12401852 | Uni-Fuse+ Infusion System 4.3F, 90cm, 10cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
30 | H787124018510 | 12401851 | Uni-Fuse+ Infusion System 4.3F, 90cm, 5cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
31 | H787124018490 | 12401849 | Uni-Fuse+ Infusion System 5F, 135cm, 10cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
32 | H787124018480 | 12401848 | Uni-Fuse+ Infusion System 5F, 135cm, 5cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
33 | H787124018460 | 12401846 | Uni-Fuse+ Infusion System 5F, 90cm, 10cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
34 | H787124018450 | 12401845 | Uni-Fuse+ Infusion System 5F, 90cm, 5cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
35 | H787124018440 | 12401844 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
36 | H787124018430 | 12401843 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
37 | H787124018420 | 12401842 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
38 | H787124018410 | 12401841 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
39 | H787124018380 | 12401838 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
40 | H787124018370 | 12401837 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
41 | H787124018360 | 12401836 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
42 | H787124018350 | 12401835 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
43 | H787124018340 | 12401834 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
44 | H787124018330 | 12401833 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
45 | H787124018320 | 12401832 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
46 | H787124018310 | 12401831 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
47 | H787124018300 | 12401830 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
48 | H787124018290 | 12401829 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
49 | H787124018280 | 12401828 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
50 | H787124018270 | 12401827 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 07290017811017 | TSUS001 | The TSP Crosser System is intended to be used both to puncture the interatrial s The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers. | TSP Crosser Transseptal Access System | TRANSSEPTAL SOLUTIONS LTD | |
2 | 07290015107242 | DRSR7463 | The Drivewire Guidewire is intended for general intravascular use, including the The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire Guidewire is intended to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. | Drivewire SR | RAPID MEDICAL LTD | |
3 | 07290015107235 | DRLR7464 | The Drivewire Guidewire is intended for general intravascular use, including the The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire Guidewire is intended to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. | Drivewire LR | RAPID MEDICAL LTD | |
4 | 06971564430395 | SW-35-180-A-3-H | Inno Hydrowire | SUZHOU INNOMED MEDICAL DEVICE . CO., LTD. | ||
5 | 06971564430210 | IW-14-190-STS | Inno-Pathwire | SUZHOU INNOMED MEDICAL DEVICE . CO., LTD. | ||
6 | 06971564430203 | IW-14-190-EXS | Inno-Pathwire | SUZHOU INNOMED MEDICAL DEVICE . CO., LTD. | ||
7 | 06971564430197 | IW-14-190-MDS | Inno-Pathwire | SUZHOU INNOMED MEDICAL DEVICE . CO., LTD. | ||
8 | 06971564430159 | SW-35-260-A-3-H | Inno Hydrowire | SUZHOU INNOMED MEDICAL DEVICE . CO., LTD. | ||
9 | 06971564430111 | SW-35-150-A-3-D | Inno Hydrowire | SUZHOU INNOMED MEDICAL DEVICE . CO., LTD. | ||
10 | 06948806356034 | S08574LL | S08574LL | Steerable Intracardiac Catheter Introducer Kit | NA | SYNAPTIC MEDICAL, LTD. |
11 | 06948806356027 | S08574LM | S08574LM | Steerable Intracardiac Catheter Introducer Kit | NA | SYNAPTIC MEDICAL, LTD. |
12 | 06948806356010 | S08574LS | S08574LS | Steerable Intracardiac Catheter Introducer Kit | NA | SYNAPTIC MEDICAL, LTD. |
13 | 06948806354122 | N18980E | N18980E | Transseptal Needle | NA | SYNAPTIC MEDICAL, LTD. |
14 | 06948806354122 | N18980E | N18980E | Transseptal Needle | NA | SYNAPTIC MEDICAL, LTD. |
15 | 06948806354115 | N18980A | N18980A | Transseptal Needle | NA | SYNAPTIC MEDICAL, LTD. |
16 | 06948806354115 | N18980A | N18980A | Transseptal Needle | NA | SYNAPTIC MEDICAL, LTD. |
17 | 06948806354047 | N18890E | N18890E | Transseptal Needle | NA | SYNAPTIC MEDICAL, LTD. |
18 | 06948806354030 | N18890A | N18890A | Transseptal Needle | NA | SYNAPTIC MEDICAL, LTD. |
19 | 06948806354023 | N18710E | N18710E | Transseptal Needle | NA | SYNAPTIC MEDICAL, LTD. |
20 | 06948806354016 | N18710A | N18710A | Transseptal Needle | NA | SYNAPTIC MEDICAL, LTD. |
21 | 06948806353194 | S0856332LM2 | S0856332LM2 | Intracardiac Catheter Introducer Kit | N/A | SYNAPTIC MEDICAL, LTD. |
22 | 06948806353187 | S0856238RM2 | Intracardiac Catheter Introducer Kit | N/A | SYNAPTIC MEDICAL, LTD. | |
23 | 06948806353170 | S0806332LM1 | Intracardiac Catheter Introducer Kit | N/A | SYNAPTIC MEDICAL, LTD. | |
24 | 06948806353163 | S0806332LM | Intracardiac Catheter Introducer Kit | N/A | SYNAPTIC MEDICAL, LTD. | |
25 | 06948806353156 | S0806332L0 | Intracardiac Catheter Introducer Kit | N/A | SYNAPTIC MEDICAL, LTD. | |
26 | 06948806353149 | S0856332L0 | Intracardiac Catheter Introducer Kit | N/A | SYNAPTIC MEDICAL, LTD. | |
27 | 06948806353132 | S0856238RM1 | Intracardiac Catheter Introducer Kit | N/A | SYNAPTIC MEDICAL, LTD. | |
28 | 06948806353125 | S0856332LM | Intracardiac Catheter Introducer Kit | N/A | SYNAPTIC MEDICAL, LTD. | |
29 | 06948806353118 | S0856332L2 | Intracardiac Catheter Introducer Kit | N/A | SYNAPTIC MEDICAL, LTD. | |
30 | 06948806353101 | S0808132L2 | Intracardiac Catheter Introducer Kit | N/A | SYNAPTIC MEDICAL, LTD. | |
31 | 06948806353095 | S0806332L2 | Intracardiac Catheter Introducer Kit | N/A | SYNAPTIC MEDICAL, LTD. | |
32 | 06948806353088 | S0858138R0 | S0858138R0 | Intracardiac Catheter Introducer Kit | NA | SYNAPTIC MEDICAL, LTD. |
33 | 06948806353071 | S0858132L1 | S0858132L1 | Intracardiac Catheter Introducer Kit | NA | SYNAPTIC MEDICAL, LTD. |
34 | 06948806353064 | S0856332L1 | S0856332L1 | Intracardiac Catheter Introducer Kit | NA | SYNAPTIC MEDICAL, LTD. |
35 | 06948806353057 | S0856238R0 | S0856238R0 | Intracardiac Catheter Introducer Kit | NA | SYNAPTIC MEDICAL, LTD. |
36 | 06948806353040 | S0808132L1 | S0808132L1 | Intracardiac Catheter Introducer Kit | NA | SYNAPTIC MEDICAL, LTD. |
37 | 06948806353033 | S0808138R0 | S0808138R0 | Intracardiac Catheter Introducer Kit | NA | SYNAPTIC MEDICAL, LTD. |
38 | 06948806353026 | S0806332L1 | S0806332L1 | Intracardiac Catheter Introducer Kit | NA | SYNAPTIC MEDICAL, LTD. |
39 | 06948806353019 | S0806238R0 | S0806238R0 | Intracardiac Catheter Introducer Kit | NA | SYNAPTIC MEDICAL, LTD. |
40 | 06947358535843 | S tip, 0.035in, 260cm | Sunmed Guide Wires | SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. | ||
41 | 06947358535812 | J tip, 0.035in, 260cm | Sunmed Guide Wires | SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. | ||
42 | 06947358535751 | S tip, 0.035in, 150cm | Sunmed Guide Wires | SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. | ||
43 | 06947358535713 | J tip, 0.035in, 150cm | Sunmed Guide Wires | SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. | ||
44 | 06947358535508 | S tip, 0.035in, 145cm | Sunmed Guide Wires | SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. | ||
45 | 06947358535317 | J tip, 0.035in, 175cm | Sunmed Guide Wires | SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. | ||
46 | 06936733740927 | RS070518S-II | The Puncture Needle incorporates a lumen, which provides a conduit for the inser The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guide Wire into the vascular system. The flexible stainless-steel guide wire is utilized as a guiding mechanism for the insertion of the Introducer Sheath into the vascular system. The Guide Wire contains a wire collimator, which assists in funneling thewire through the lumen of the Puncture Needle. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy and provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated Sheath Introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The Dilator is used to provide support and stability to the Sheath Introducer during deployment into the vascular system. The proximal end of the Dilator includes a luer port and has a tapered, atraumatic distal tip. There is no radiocontrast agent on the dilator. | Shoocin | LEPU MEDICAL TECHNOLOGY (BEIJING) CO.,LTD. | |
47 | 06936733740910 | RS061118S-II | The Puncture Needle incorporates a lumen, which provides a conduit for the inser The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guide Wire into the vascular system. The flexible stainless-steel guide wire is utilized as a guiding mechanism for the insertion of the Introducer Sheath into the vascular system. The Guide Wire contains a wire collimator, which assists in funneling thewire through the lumen of the Puncture Needle. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy and provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated Sheath Introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The Dilator is used to provide support and stability to the Sheath Introducer during deployment into the vascular system. The proximal end of the Dilator includes a luer port and has a tapered, atraumatic distal tip. There is no radiocontrast agent on the dilator. | Shoocin | LEPU MEDICAL TECHNOLOGY (BEIJING) CO.,LTD. | |
48 | 06936733740903 | RS060725S-II | The Puncture Needle incorporates a lumen, which provides a conduit for the inser The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guide Wire into the vascular system. The flexible stainless-steel guide wire is utilized as a guiding mechanism for the insertion of the Introducer Sheath into the vascular system. The Guide Wire contains a wire collimator, which assists in funneling thewire through the lumen of the Puncture Needle. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy and provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated Sheath Introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The Dilator is used to provide support and stability to the Sheath Introducer during deployment into the vascular system. The proximal end of the Dilator includes a luer port and has a tapered, atraumatic distal tip. There is no radiocontrast agent on the dilator. | Shoocin | LEPU MEDICAL TECHNOLOGY (BEIJING) CO.,LTD. | |
49 | 06936733740897 | RS060721S-II | The Puncture Needle incorporates a lumen, which provides a conduit for the inser The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guide Wire into the vascular system. The flexible stainless-steel guide wire is utilized as a guiding mechanism for the insertion of the Introducer Sheath into the vascular system. The Guide Wire contains a wire collimator, which assists in funneling thewire through the lumen of the Puncture Needle. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy and provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated Sheath Introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The Dilator is used to provide support and stability to the Sheath Introducer during deployment into the vascular system. The proximal end of the Dilator includes a luer port and has a tapered, atraumatic distal tip. There is no radiocontrast agent on the dilator. | Shoocin | LEPU MEDICAL TECHNOLOGY (BEIJING) CO.,LTD. | |
50 | 06936733740880 | RS060718S-II | The Puncture Needle incorporates a lumen, which provides a conduit for the inser The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guide Wire into the vascular system. The flexible stainless-steel guide wire is utilized as a guiding mechanism for the insertion of the Introducer Sheath into the vascular system. The Guide Wire contains a wire collimator, which assists in funneling thewire through the lumen of the Puncture Needle. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy and provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated Sheath Introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The Dilator is used to provide support and stability to the Sheath Introducer during deployment into the vascular system. The proximal end of the Dilator includes a luer port and has a tapered, atraumatic distal tip. There is no radiocontrast agent on the dilator. | Shoocin | LEPU MEDICAL TECHNOLOGY (BEIJING) CO.,LTD. |