No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850004312025 | SS085075M | PN1008533-002 | The Steerable introducer sheath consists of a steerable sheath connected to a ha The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device. | DYB | Introducer, Catheter | 2 | Steerable Introducer Sheath 8.5F Medium Curl |
2 | 00850004312049 | SS120065 | PN1008533-004 | The Steerable introducer sheath consists of a steerable sheath connected to a ha The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration.The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device. | DRA | Catheter, Steerable | 2 | Steerable Introducer Sheath 12F |
3 | 00850004312001 | 668782-100 | PN1007960-100 | The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use disposable introducer sheath and dilator that is inserted into the peripheral vasculature to support the introduction of diagnostic or interventional devices, while minimizing blood loss associated with such insertions. The EMPOWER™ Introducer Sheath is coil-reinforced and coated with a lubricious hydrophilic coating. The EMPOWER™ hemostasis valve is integrated into the sheath hub and features a variable aperture seal for enhanced control over device insertion while maintaining hemostasis. The valve is normally closed until the user squeezes the actuator levers to proportionally open the valve and receive any device up to its labeled size. A sideport extends from the EMPOWER™ valve housing with a 3-way stopcock.The radiopaque dilator is designed to accommodate an .035” (0.89mm) guidewire and includes a proximal hub grip with a female luer taper fitting for flushing. Prior to insertion, the dilator hub can be secured to the EMPOWER™ housing with a quarter-turn twist. | DYB | Introducer, Catheter | 2 | EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING |
4 | 00850004312032 | SS085075L | PN1008533-003 | The Steerable introducer sheath consists of a steerable sheath connected to a ha The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device. | DYB | Introducer, Catheter | 2 | Steerable Introducer Sheath 8.5F Large Curl |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 07613327116670 | 0911182000 | 0911182000 | Cournand 2 piece | NA | STRYKER CORPORATION |
2 | 07613327115970 | 0914197000 | 0914197000 | Arterial 1 piece | NA | STRYKER CORPORATION |
3 | 07613327115963 | 0914187000 | 0914187000 | Arterial 1 piece | NA | STRYKER CORPORATION |
4 | 07613327115956 | 0913197000 | 0913197000 | Flashback 1 piece | NA | STRYKER CORPORATION |
5 | 07613327115949 | 0913187000 | 0913187000 | Flashback 1 piece | NA | STRYKER CORPORATION |
6 | 07613327115932 | 0912197000 | 0912197000 | Seldinger 2 piece | NA | STRYKER CORPORATION |
7 | 07613327115925 | 0912194000 | 0912194000 | Seldinger 2 piece | NA | STRYKER CORPORATION |
8 | 07613327115918 | 0912190000 | 0912190000 | Seldinger 2 piece | NA | STRYKER CORPORATION |
9 | 07613327115901 | 0912188000 | 0912188000 | Seldinger 2 piece | NA | STRYKER CORPORATION |
10 | 07613327115895 | 0912187000 | 0912187000 | Seldinger 2 piece | NA | STRYKER CORPORATION |
11 | 07613327115888 | 0911192000 | 0911192000 | Cournand 2-Part Introducer | NA | STRYKER CORPORATION |
12 | H965481080 | 48-108 | GUIDEWIRE, 0.018 X 65CM Ni/Tu | Navylist | NAVILYST MEDICAL, INC. | |
13 | H965481040 | 48-104 | NEEDLE 18G X 15CM CHIBA STYLET ECHO TIP | ENVI | NAVILYST MEDICAL, INC. | |
14 | H965481030 | 48-103 | NEEDLE 21G X 15CM TROCAR STYLET ECHO TIP | ENVI | NAVILYST MEDICAL, INC. | |
15 | H965481020 | 48-102 | NEEDLE, 21G X 15CM CHIBA STYLET ECHO TIP | ENVI | NAVILYST MEDICAL, INC. | |
16 | H965481010 | 48-101 | GUIDEWIRE, 0.018 X 65CM Ni/Tu | ENVI | NAVILYST MEDICAL, INC. | |
17 | H965481000 | 48-100 | NVI SHEATH 6F X 20CM | ENVI | NAVILYST MEDICAL, INC. | |
18 | H965355200 | 35-520 | NEEDLE 18G X 15 CHIBA STYLET ECHO TIP GUIDEWIRE, 0.035 X 150CM | ENVI | NAVILYST MEDICAL, INC. | |
19 | H965355190 | 35-519 | NEEDLE 18G X 15 CHIBA STYLET ECHO TIP | ENVI | NAVILYST MEDICAL, INC. | |
20 | H965355180 | 35-518 | NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 150 ROSEN-PTFE | ENVI | NAVILYST MEDICAL, INC. | |
21 | H965355170 | 35-517 | NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 80 ROSEN-PTFE | ENVI | NAVILYST MEDICAL, INC. | |
22 | H965355160 | 35-516 | NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 150 ROSEN-PTFE | ENVI | NAVILYST MEDICAL, INC. | |
23 | H965355150 | 35-515 | NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 80 ROSEN-PTFE | ENVI | NAVILYST MEDICAL, INC. | |
24 | H965355140 | 35-514 | NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 150 ROSEN-PTFE | ENVI | NAVILYST MEDICAL, INC. | |
25 | H965355130 | 35-513 | NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 80 ROSEN-PTFE | ENVI | NAVILYST MEDICAL, INC. | |
26 | H965355120 | 35-512 | NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 150 ROSEN-PTFE | ENVI | NAVILYST MEDICAL, INC. | |
27 | H965355110 | 35-510 | NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 80 ROSEN-PTFE | ENVI | NAVILYST MEDICAL, INC. | |
28 | H965355100 | 35510_DI | STYLET 21G C 24CM SS | ENVI | NAVILYST MEDICAL, INC. | |
29 | H965355090 | 35-509 | NVI MINI STICK 6F X 20CM 21G TROCAR ECHO | ENVI | NAVILYST MEDICAL, INC. | |
30 | H965355080 | 35-508 | NVI MINI STICK 6F X 20CM 21G CHIBA ECHO | ENVI | NAVILYST MEDICAL, INC. | |
31 | H965355070 | 35-507 | NVI MINI STICK 6F X 20 CM .018 Ni/Tu 21G TROCAR | ENVI | NAVILYST MEDICAL, INC. | |
32 | H965355060 | 35-506 | NVI MINI STICK 6F X 20 CM .018 Ni/Tu 21G CHIBA ECHO TIP | ENVI | NAVILYST MEDICAL, INC. | |
33 | H965355050 | 35-505 | NEEDLE 18G X 15CM CHIBA STYLET | ENVI | NAVILYST MEDICAL, INC. | |
34 | H965355040 | 35-504 | NEEDLE 21G X 15CM TROCAR STYLET ECHO TIP | ENVI | NAVILYST MEDICAL, INC. | |
35 | H965355030 | 35-503 | NEEDLE 21G X 15CM CHIBA STYLET ECHO TIP | ENVI | NAVILYST MEDICAL, INC. | |
36 | H965355020 | 35-502 | GUIDEWIRE 0.018 X 65CM Ti/Tu | ENVI | NAVILYST MEDICAL, INC. | |
37 | H965355010 | 35-501 | NVI SHEATH 6F X 20CM | ENVI | NAVILYST MEDICAL, INC. | |
38 | H862PS238SW0 | PS2-38SW | PS2-38SW | Posi-Stick Intro. Set w/PT Marker & .038" Super-Stiff GW | Posi-Stick Introducer Set | URESIL, LLC |
39 | H862PS2380 | PS2-38 | PS2-38 | Posi-Stick Intro. Set w/PT Marker & .038" & .018" GW | Posi-Stick Introducer Set | URESIL, LLC |
40 | H862PS235SW0 | PS2-35SW | PS2-35SW | Posi-Stick Intro. Set w/PT Marker & .035" Super-Stiff GW | Posi-Stick Introducer Set | URESIL, LLC |
41 | H862PS2350 | PS2-35 | PS2-35 | Posi-Stick Intro. Set w/PT Marker & .035" & .018" GW | Posi-Stick Introducer Set | URESIL, LLC |
42 | H862PS21S0 | PS2-1S | PS2-1S | Posi-Stick One-Step | Posi-Stick Introducer Set | URESIL, LLC |
43 | H862PS2000 | PS2-00 | PS2-00 | Posi-Stick Introducer Set w/PT Marker | Posi-Stick Introducer Set | URESIL, LLC |
44 | H787565970030 | 56597003 | Standard Micro Introducer Kit | AngioDynamics | ANGIODYNAMICS, INC. | |
45 | H787165100010 | 16510001 | Venacure EVLT NeverTouch Direct Introducer Sheath | VenaCure | ANGIODYNAMICS, INC. | |
46 | H787065972020 | 06597202 | Stainless Steel Guidewire w/ Tungsten Tip | AngioDynamics | ANGIODYNAMICS, INC. | |
47 | H787065972010 | 06597201 | Nitinol Guidewire w/ Tungsten Tip | AngioDynamics | ANGIODYNAMICS, INC. | |
48 | H787065971040 | 06597104 | Stiffened Micro Introducer | AngioDynamics | ANGIODYNAMICS, INC. | |
49 | H787065971030 | 06597103 | Stiffened Micro Introducer | AngioDynamics | ANGIODYNAMICS, INC. | |
50 | H787065971020 | 06597102 | Standard Micro Introducer | AngioDynamics | ANGIODYNAMICS, INC. |