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 | B611955121 | 95512 | 95512 | SERI Contour Surgical Scaffold 10cm x 25cm | SERI Contour | SOFREGEN MEDICAL INC. |
2 | B6119468001 | 94679 | SERI Surgical Scaffold 10cm x 25cm | SERI | SOFREGEN MEDICAL INC. | |
3 | B6119467909 | 94680 | SERI Surgical Scaffold 5cm x 15cm | SERI | SOFREGEN MEDICAL INC. | |
4 | B6119467808 | 94678 | SERI Surgical Scaffold 20cm x 30cm | SERI | SOFREGEN MEDICAL INC. | |
5 | B6119467707 | 94677 | SERI Surgical Scaffold 15cm x 25cm | SERI | SOFREGEN MEDICAL INC. | |
6 | 10705036023296 | ECH60R | ECH60R | ECHELON 60MM REINFORCEMENT | ECHLEON | ETHICON ENDO-SURGERY, LLC |
7 | 07332999000093 | NSTM1520 | NSTM1520 | TIGR® Matrix Surgical Mesh | NOVUS SCIENTIFIC AB | |
8 | 07332999000024 | NSTM2030 | NSTM2030 | TIGR® Matrix Surgical Mesh | NOVUS SCIENTIFIC AB | |
9 | 07332999000017 | NSTM1015 | NSTM1015 | TIGR® Matrix Surgical Mesh | NOVUS SCIENTIFIC AB | |
10 | 04548366322481 | NV-L-015G | NV-L-015G | As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 1 As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon.Two forms of NEOVEIL are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL staple line reinforcement ranges from 0.1 mm to 0.85 mm.Mesh weave characteristics and pore size are not applicable since NEOVEIL is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m2). | NEOVEIL | GUNZE LIMITED |
11 | 04547301462558 | NV-ET-M60E-2 | NV-ET-M60E-2 | As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 1 As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon.Two forms of NEOVEIL are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL staple line reinforcement ranges from 0.1 mm to 0.85 mm.Mesh weave characteristics and pore size are not applicable since NEOVEIL is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m2). | NEOVEIL | GUNZE LIMITED |
12 | 04547301462534 | NV-ET-M60A-2 | NV-ET-M60A-2 | As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 1 As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon.Two forms of NEOVEIL are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL staple line reinforcement ranges from 0.1 mm to 0.85 mm.Mesh weave characteristics and pore size are not applicable since NEOVEIL is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m2). | NEOVEIL | GUNZE LIMITED |
13 | 00801741163258 | 1223035 | 1223035 | Phasix™ ST Mesh with Open Positioning System, Oval | Phasix™ ST Mesh with Open Positioning System | DAVOL INC. |
14 | 00801741163241 | 1222530 | 1222530 | Phasix™ ST Mesh with Open Positioning System, Oval | Phasix™ ST Mesh with Open Positioning System | DAVOL INC. |
15 | 00801741163234 | 1222025 | 1222025 | Phasix™ ST Mesh with Open Positioning System,Oval | Phasix™ ST Mesh with Open Positioning System | DAVOL INC. |
16 | 00801741163227 | 1221530 | 1221530 | Phasix™ ST Mesh with Open Positioning System, Oval | Phasix™ ST Mesh with Open Positioning System, | DAVOL INC. |
17 | 00801741163210 | 1221520 | 1221520 | Phasix™ ST Mesh with Open Positioning System, Oval | Phasix™ ST Mesh with Open Positioning System, | DAVOL INC. |
18 | 00801741163203 | 1221015 | 1221015 | Phasix™ ST Mesh with Open Positioning System, Oval | Phasix™ ST Mesh with Open Positioning System, | DAVOL INC. |
19 | 00801741163197 | 1220812 | 1220812 | Phasix™ ST Mesh with Open Positioning System, Oval | Phasix™ ST Mesh with Open Positioning System, | DAVOL INC. |
20 | 00801741163173 | 1220011 | 1220011 | Phasix™ ST Mesh with Open Positioning System, Circle | Phasix™ ST Mesh with Open Positioning System | DAVOL INC. |
21 | 00801741161308 | 1213035 | 1213035 | Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse | Phasix™ ST Mesh with Echo 2™ Positioning System | DAVOL INC. |
22 | 00801741161292 | 1212533 | 1212533 | Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse | Phasix™ ST Mesh with Echo 2™ Positioning System | DAVOL INC. |
23 | 00801741161285 | 1212025 | 1212025 | Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse | Phasix™ ST Mesh with Echo 2™ Positioning System | DAVOL INC. |
24 | 00801741161278 | 1211823 | 1211823 | Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse | Phasix™ ST Mesh with Echo 2™ Positioning System | DAVOL INC. |
25 | 00801741161261 | 1211525 | 1211525 | Phasix™ ST Mesh with Echo 2™ Positioning System, Oval | Phasix™ ST Mesh with Echo 2™ Positioning System | DAVOL INC. |
26 | 00801741161254 | 1211520 | 1211520 | Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse | Phasix™ ST Mesh with Echo 2™ Positioning System | DAVOL INC. |
27 | 00801741161247 | 1211015 | 1211015 | Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse | Phasix™ ST Mesh with Echo 2™ Positioning System | DAVOL INC. |
28 | 00801741161230 | 1210020 | 1210020 | Phasix™ ST Mesh with Echo 2™ Positioning System, Circle | Phasix™ ST Mesh with Echo 2™ Positioning System | DAVOL INC. |
29 | 00801741161223 | 1210015 | 1210015 | Phasix™ ST with Echo 2™ Positioning System, Circle | Phasix™ ST Mesh with Echo 2™ Positioning System | DAVOL INC. |
30 | 00801741161216 | 1210011 | 1210011 | Phasix™ ST Mesh with Echo 2™ Positioning System, Circle | Phasix™ ST Mesh with Echo 2™ Positioning System | DAVOL INC. |
31 | 00801741095382 | 1203035 | 1203035 | Phasix ST Mesh, Rectangle | Phasix ST Mesh | DAVOL INC. |
32 | 00801741095375 | 1202530 | 1202530 | Phasix ST Mesh, Rectangle | Phasix ST Mesh | DAVOL INC. |
33 | 00801741095368 | 1202025 | 1202025 | Phasix ST Mesh, Rectangle | Phasix ST Mesh | DAVOL INC. |
34 | 00801741095351 | 1201520 | 1201520 | Phasix ST Mesh, Rectangle | Phasix ST Mesh | DAVOL INC. |
35 | 00801741095344 | 1201015 | 1201015 | Phasix ST Mesh, Rectangle | Phasix ST Mesh | DAVOL INC. |
36 | 00801741095337 | 1200710 | 1200710 | Phasix ST Mesh, Rectangle | Phasix ST Mesh | DAVOL INC. |
37 | 00801741095320 | 1201010 | 1201010 | Phasix ST Mesh, Square | Phasix ST Mesh | DAVOL INC. |
38 | 00801741095313 | 1201020 | 1201020 | Phasix ST Mesh, Rectangle | Phasix ST Mesh | DAVOL INC. |
39 | 00801741095306 | 1201325 | 1201325 | Phasix ST Mesh, Rectangle | Phasix ST Mesh | DAVOL INC. |
40 | 00801741095290 | 1200015 | 1200015 | Phasix ST Mesh, Circle | Phasix ST Mesh | DAVOL INC. |
41 | 00801741095283 | 1200011 | 1200011 | Phasix ST Mesh, Circle | Phasix ST Mesh | DAVOL INC. |
42 | 00801741095276 | 1200008 | 1200008 | Phasix ST Mesh, Circle | Phasix ST Mesh | DAVOL INC. |
43 | 00801741010637 | 1190603 | 1190603 | Phasix Plug and Patch Extra Large | Phasix Plug and Patch | DAVOL INC. |
44 | 00801741010620 | 1190602 | 1190602 | Phasix Plug and Patch Large | Phasix Plug and Patch | DAVOL INC. |
45 | 00801741010613 | 1190601 | 1190601 | Phasix Plug and Patch Medium | Phasix Plug and Patch | DAVOL INC. |
46 | 00801741010606 | 1190600 | 1190600 | Phasix Plug and Patch Small | Phasix Plug and Patch | DAVOL INC. |
47 | 00733132644780 | 20055721 | 20055721 | IntuitiveDaVinciXi60Black | GORE SEAMGUARD Bioabsorbable Staple Line Reinforce | W. L. GORE & ASSOCIATES, INC. |
48 | 00733132644773 | 20055724 | 20055724 | IntuitiveDaVinciXi60Green | GORE SEAMGUARD Bioabsorbable Staple Line Reinforce | W. L. GORE & ASSOCIATES, INC. |
49 | 00733132644728 | GBFR2540 | GBFR2540 | GORE ENFORM Intraperitoneal Biomaterial | W. L. GORE & ASSOCIATES, INC. | |
50 | 00733132644728 | GBFR2540 | GBFR2540 | GORE ENFORM Intraperitoneal Biomaterial | W. L. GORE & ASSOCIATES, INC. |