No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00733132638895 | VSWVN0804 | VSWVN0804 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
2 | 00733132638888 | VSWVN1010 | VSWVN1010 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
3 | 00733132638871 | VSWVN1008 | VSWVN1008 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
4 | 00733132638864 | VSWVN1006 | VSWVN1006 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
5 | 00733132638857 | VSWVN1004 | VSWVN1004 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
6 | 00733132638840 | VSWVN0810 | VSWVN0810 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
7 | 00733132638833 | VSWVN0808 | VSWVN0808 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
8 | 00733132638826 | VSWVN0806 | VSWVN0806 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
9 | 00733132638819 | VSWVH1010 | VSWVH1010 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
10 | 00733132638802 | VSWVH1008 | VSWVH1008 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
11 | 00733132638796 | VSWVH1006 | VSWVH1006 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
12 | 00733132638789 | VSWVH0810 | VSWVH0810 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
13 | 00733132638772 | VSWVH0808 | VSWVH0808 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
14 | 00733132638765 | VSWVH0806 | VSWVH0806 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
15 | 00733132618286 | GEFA017300 | GEFA017300 | 7MM FILTER ON 300CM GUIDEWIRE | NTE | Temporary Carotid Catheter for Embolic Capture | 2 | GORE Embolic Filter |
16 | 00733132618279 | GEFA015185 | GEFA015185 | 5MM FILTER ON 185CM GUIDEWIRE | NTE | Temporary Carotid Catheter for Embolic Capture | 2 | GORE Embolic Filter |
17 | 00733132618262 | GEFA015300 | GEFA015300 | 5MM FILTER ON 300CM GUIDEWIRE | NTE | Temporary Carotid Catheter for Embolic Capture | 2 | GORE Embolic Filter |
18 | 00733132618255 | GEFA017185 | GEFA017185 | 7MM FILTER ON 185CM GUIDEWIRE | NTE | Temporary Carotid Catheter for Embolic Capture | 2 | GORE Embolic Filter |
19 | 00733132617609 | GSXA0015 | GSXA0015 | GORE SEPTAL OCCLUDER 15MM ASD | MLV | Transcatheter Septal Occluder | 3 | Gore Septal Occluder |
20 | 00733132615797 | VN1008200 | VN1008200 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
21 | 00733132615773 | VN1008040 | VN1008040 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
22 | 00733132615759 | VN1006200 | VN1006200 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
23 | 00733132615735 | VN1006040 | VN1006040 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
24 | 00733132615711 | VN1004200 | VN1004200 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
25 | 00733132615698 | VN1004040 | VN1004040 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
26 | 00733132615674 | VN0810200 | VN0810200 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
27 | 00733132615650 | VN0810040 | VN0810040 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
28 | 00733132615636 | VN0808200 | VN0808200 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
29 | 00733132615612 | VN0808040 | VN0808040 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
30 | 00733132615599 | VN0806200 | VN0806200 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
31 | 00733132615575 | VN0806040 | VN0806040 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
32 | 00733132615551 | VN0804200 | VN0804200 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
33 | 00733132615537 | VN0804040 | VN0804040 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
34 | 00733132615520 | VH1010200 | VH1010200 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
35 | 00733132615513 | VH1010040 | VH1010040 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
36 | 00733132615506 | VH1008200 | VH1008200 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
37 | 00733132615483 | VH1006200 | VH1006200 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
38 | 00733132615476 | VH1006040 | VH1006040 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
39 | 00733132615469 | VH0810200 | VH0810200 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
40 | 00733132615452 | VH0810040 | VH0810040 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
41 | 00733132615445 | VH0808200 | VH0808200 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
42 | 00733132615438 | VH0808040 | VH0808040 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
43 | 00733132615421 | VH0806200 | VH0806200 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
44 | 00733132615414 | VH0806040 | VH0806040 | FGE | Catheter, Biliary, Diagnostic | 2 | GORE VIABIL Biliary Endoprosthesis | |
45 | 00733132612154 | SDV2028 | SDV2028 | SDV INTRODUCER SHEATH 20F | DYB | INTRODUCER, CATHETER | 2 | GORE DrySeal Sheath |
46 | 00733132612147 | SDV1828 | SDV1828 | SDV INTRODUCER SHEATH 18F | DYB | INTRODUCER, CATHETER | 2 | GORE DrySeal Sheath |
47 | 00733132612123 | SDV1428 | SDV1428 | SDV INTRODUCER SHEATH 14F | DYB | INTRODUCER, CATHETER | 2 | GORE DrySeal Sheath |
48 | 00733132612116 | SDV1228 | SDV1228 | SDV INTRODUCER SHEATH 12F | DYB | INTRODUCER, CATHETER | 2 | GORE DrySeal Sheath |
49 | 00733132607303 | IRST08080080L | IRST08080080L | INTERING STR T8MM 80CM RS X 80 | DSY | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 2 | GORE INTERING Vascular Graft |
50 | 00733132602001 | 1PDX307 | 1PDX307 | GXQ | Dura Substitute | 2 | GORE PRECLUDE PDX Dura Substitute |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00850027837611 | 900309 | AcQCross Qx Integrated Transseptal Dilator/Needle | ACUTUS MEDICAL, INC. | ||
2 | 00850027837598 | 900308 | AcQCross Qx Integrated Transseptal Dilator/Needle | ACUTUS MEDICAL, INC. | ||
3 | 00850027837574 | 900307 | AcQCross Qx Integrated Transseptal Dilator/Needle | ACUTUS MEDICAL, INC. | ||
4 | 00850027837550 | 900306 | AcQCross Qx Integrated Transseptal Dilator/Needle | ACUTUS MEDICAL, INC. | ||
5 | 00850027837161 | 900305 | 900305 | AcQCross Qx - MAX 70cm | AcQCross Qx | ACUTUS MEDICAL, INC. |
6 | 00850027837147 | 900304 | 900304 | AcQCross Qx - FC 65cm | AcQCross Qx | ACUTUS MEDICAL, INC. |
7 | 00850027837123 | 900303 | 900303 | AcQCross Qx - VZ 71cm | AcQCross Qx | ACUTUS MEDICAL, INC. |
8 | 00850027837109 | 900302 | 900302 | AcQCross Qx - SL 63cm | AcQCross Qx | ACUTUS MEDICAL, INC. |
9 | 00850027837086 | 900300 | 900300 | AcQCross Qx - AG 61cm | AcQCross Qx | ACUTUS MEDICAL, INC. |
10 | 00850027837055 | 900301 | 900301 | AcQCross Qx - AG 71cm | AcQCross Qx | ACUTUS MEDICAL, INC. |
11 | 00850021246082 | CW-STS8F25 | Steerable Transseptal Sheath | CrossWise | KALILA MEDICAL, INC. | |
12 | 00850020653003 | SS-001 | FG00006 | XactTS Steerable Transseptal Catheter | KEYSTONE HEART LTD | |
13 | 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. | Steerable Introducer Sheath 8.5F Large Curl | FREUDENBERG MEDICAL, LLC |
14 | 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. | Steerable Introducer Sheath 8.5F Medium Curl | FREUDENBERG MEDICAL, LLC |
15 | 00850004312018 | SS085075S | PN1008533-001 | 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. | Steerable Introducer Sheath 8.5F Small Curl | FREUDENBERG MEDICAL, LLC |
16 | 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. | EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING | FREUDENBERG MEDICAL, LLC |
17 | 00850004162200 | VGHIS04 | VGHIS04 | VGHIS04 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
18 | 00850004162194 | VGHIS03 | VGHIS03 | VGHIS03 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
19 | 00850004162187 | VGHIS02 | VGHIS02 | VGHIS02 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
20 | 00850004162170 | VGHIS01 | VGHIS01 | VGHIS01 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
21 | 00850004162163 | VGHIS00 | VGHIS00 | VGHIS00 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
22 | 00850004162156 | VGCTR04A | VGCTR04A | VGCTR04A INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
23 | 00850004162149 | VGCTR04 | VGCTR04 | VGCTR04 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
24 | 00850004162132 | VGCTR03A | VGCTR03A | VGCTR03A INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
25 | 00850004162125 | VGCTR03 | VGCTR03 | VGCTR03 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
26 | 00849884004311 | VYAA21G7S | VYAA21G7S | 21GA SAFETY NEEDLE, 7CM | VYGON | VYGON CORPORATION |
27 | 00849884004304 | VYAA21G7 | VYAA21G7 | 21GA. X 7CM INTRODUCER NEEDLE | VYGON | VYGON CORPORATION |
28 | 00849884004298 | VYAA21G4S | VYAA21G4S | 21GA SAFETY NEEDLE, 4CM | VYGON | VYGON CORPORATION |
29 | 00849884004281 | VYAA21G4 | VYAA21G4 | 21GA. X 4CM INTRODUCER NEEDLE | VYGON | VYGON CORPORATION |
30 | 00849884004274 | VYAA21G2 | VYAA21G2 | 21GA. X 2.5CM INTRODUCER NEEDLE | VYGON | VYGON CORPORATION |
31 | 00849884004267 | VY-NDL3F | VY-NDL3F | 3FR FLARED NEEDLE | VYGON | VYGON CORPORATION |
32 | 00849884004250 | VAT6007 | VAT6007 | 6F X 7CM PTFE TEARAWAY INTRODUCER | VYGON | VYGON CORPORATION |
33 | 00849884004243 | VAT5510 | VAT5510 | 5.5F X 10CM PTFE TEARAWAY INTRODUCER | VYGON | VYGON CORPORATION |
34 | 00849884004236 | VAT5507 | VAT5507 | 5.5F X 7CM PTFE TEARAWAY INTRODUCER | VYGON | VYGON CORPORATION |
35 | 00849884004229 | VAT4510 | VAT4510 | 4.5F X 10CM PTFE TEARAWAY INTRODUCER | VYGON | VYGON CORPORATION |
36 | 00849884004212 | VAT4007 | VAT4007 | 4.0F X 7CM PTFE TEARAWAY INTRODUCER | VYGON | VYGON CORPORATION |
37 | 00849884004205 | VAT3005 | VAT3005 | 3.5F X 5CM PTFE TEARAWAY INTRODUCER | VYGON | VYGON CORPORATION |
38 | 00849884002362 | 1262.30N | 1262.30N | 20 GA. SPLITTING INTRODUCER NEEDLE | VYGON | VYGON CORPORATION |
39 | 00849884002041 | 7371.19 | 7371.19 | MICROFLASH INTRODUCER 2FR | VYGON | VYGON CORPORATION |
40 | 00846835012388 | D140010 | D140010 | Bi-Directional Guiding Sheath, Small Curve | MobiCath™ | GREATBATCH LTD |
41 | 00846835012371 | D140011 | D140011 | MobiCath BiDirectional Guiding Sheath, Large Curve | MobiCath™ | GREATBATCH LTD |
42 | 00841268109780 | INT-128-17 | INT-128-17 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
43 | 00841268109773 | INT-128-16 | INT-128-16 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
44 | 00841268109766 | INT-128-15 | INT-128-15 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
45 | 00841268109759 | INT-128-04 | INT-128-04 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
46 | 00841268109742 | INT-128-03 | INT-128-03 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
47 | 00841268109735 | INT-128-02 | INT-128-02 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
48 | 00841268109728 | INT-128-01 | INT-128-01 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
49 | 00841268109643 | INT-117-16 | INT-117-16 | Tearaway Sheath Introducer | Tearaway Sheath Introducer | GALT MEDICAL CORP. |
50 | 00841268109599 | INT-116-16 | INT-116-16 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |