| 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 | 00857042007678 | 212852 | 212852 | AcQGuide Mini RF 65 cm - L2 with AcQCross Qx | AcQGuide Mini | ACUTUS MEDICAL, INC. |
| 2 | 00857042007517 | 222852 | 222852 | AcQGuide Flex RF 65 cm Med Curl | AcQGuide Flex | ACUTUS MEDICAL, INC. |
| 3 | 00857042007500 | 012852 | 012852 | AcQGuide Mini-S, 65cm - L2 with AcQCross QX | AcQGuide Mini-S | ACUTUS MEDICAL, INC. |
| 4 | 00857042007456 | 122852 | 122852 | AcQGuide Flex 65 cm Med Curl with AcQCross QX | AcQGuide | ACUTUS MEDICAL, INC. |
| 5 | 00857042007432 | 112852 | AcQGuide Mini 65cm - L2 with AcQCross QX | AcQGuide | ACUTUS MEDICAL, INC. | |
| 6 | 00857042007142 | 900005 | 900005 | AcQRef Introducer Sheath | AcQRef | ACUTUS MEDICAL, INC. |
| 7 | 00855975007055 | XE501 | Encapsulator 16mm x 70cm | XCOIL Encapsulator | NEXGEN MEDICAL SYSTEMS, INC. | |
| 8 | 00855975007048 | XE400 | XCOIL Encapsulator - 11mm x 80cm | XCOIL Encapsulator | NEXGEN MEDICAL SYSTEMS, INC. | |
| 9 | 00852392007057 | 112852 | Guider - 65cm - L2 Guider Catheter Introducer 65 L2 8.5F | Guider Catheter Introducer | RHYTHM XIENCE, INC. | |
| 10 | 00852392007040 | 111852 | Guider - 65cm - L1 Guider Catheter Introducer 65 L1 8.5F | Guider Catheter Introducer | RHYTHM XIENCE, INC. | |
| 11 | 00852392007033 | 112851 | Guider - 50cm - L2 Guider Catheter Introducer 50 L2 8.5F | Guider Catheter Introducer | RHYTHM XIENCE, INC. | |
| 12 | 00852392007026 | 111851 | Guider - 50cm - L1 Guider Catheter Introducer 50 L1 8.5F | Guider Catheter Introducer | RHYTHM XIENCE, INC. | |
| 13 | 00852392007019 | 122852 | Flextra - 65cm - MED Curl Flextra Steerable Introducer 65cm Med Curl 8.5F | Flextra Steerable Introducer | RHYTHM XIENCE, INC. | |
| 14 | 00852392007002 | 122851 | Flextra - 50cm - MED Curl Flextra Steerable Introducer 50cm Med Curl 8.5F | Flextra Steerable Introducer | RHYTHM XIENCE, INC. | |
| 15 | 00852381011904 | SR-2035 | SR-2035 | SOLOPATH Re-collapsible Balloon Access System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 16 | 00852381011898 | SR-2025 | SR-2025 | SOLOPATH Re-collapsible Balloon Access System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 17 | 00852381004418 | SR-2435 | SR-2435 | SOLOPATH Re-collapsible Access System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 18 | 00852381004401 | SR-2425 | SR-2425 | SOLOPATH Re-collapsible Access System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 19 | 00852381004395 | SR-2235 | SR-2235 | SOLOPATH Re-collapsible Access System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 20 | 00852381004388 | SR-2225 | SR-2225 | SOLOPATH Re-collapsible Access System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 21 | 00852381004357 | SR-1935 | SR-1935 | SOLOPATH Re-collapsible Access System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 22 | 00852381004340 | SR-1925 | SR-1925 | SOLOPATH Re-collapsible Access System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 23 | 00852381004319 | STFI-2135 | STFI-2135 | SOLOPATH Balloon Expandable TransFemoral System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 24 | 00852381004302 | STFI-2125 | STFI-2125 | SOLOPATH Balloon Expandable TransFemoral System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 25 | 00852381004272 | STFI-1935 | STFI-1935 | SOLOPATH Balloon Expandable TransFemoral System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 26 | 00852381004265 | STFI-1925 | STFI-1925 | SOLOPATH Balloon Expandable TransFemoral System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 27 | 00852381004258 | STFI-1835 | STFI-1835 | SOLOPATH Balloon Expandable TransFemoral System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 28 | 00852381004241 | STFI-1825 | STFI-1825 | SOLOPATH Balloon Expandable TransFemoral System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 29 | 00852381004234 | STFI-1635 | STFI-1635 | SOLOPATH Balloon Expandable TransFemoral System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 30 | 00852381004227 | STFI-1625 | STFI-1625 | SOLOPATH Balloon Expandable TransFemoral System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 31 | 00852381004210 | STFI-1435 | STFI-1435 | SOLOPATH Balloon Expandable TransFemoral System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 32 | 00852381004203 | STFI-1425 | STFI-1425 | SOLOPATH Balloon Expandable TransFemoral System | SOLOPATH | ONSET MEDICAL CORPORATION |
| 33 | 00852004007024 | PSS-20-0612200-SCN | The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath wi The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer,a vessel dilator and guidewire. Used in conjunction with the Endophys Blood Pressure Monitor it is used to continuously monitor patient blood pressure during procedure requiring vascular access. | Endophys Pressure Sensing Sheath Kit-6F | ENDOPHYS HOLDINGS, LLC | |
| 34 | 00852004007017 | PSS-20-0612200-ECN | The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath wi The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer,a vessel dilator and guidewire. Used in conjunction with the Endophys Blood Pressure Monitor it is used to continuously monitor patient blood pressure during procedure requiring vascular access. | Endophys Pressure Sensing Sheath Kit-6F | ENDOPHYS HOLDINGS, LLC | |
| 35 | 00850232006123 | TG0855522 | TG0855522 | Steerable Sheath, 8.5F | TourGuide™ Steerable Sheath | OSCOR INC. |
| 36 | 00850232006116 | TG0855517 | TG0855517 | Steerable Sheath, 8.5F | TourGuide™ Steerable Sheath | OSCOR INC. |
| 37 | 00850232006109 | TG0854522 | TG0854522 | Steerable Sheath, 8.5F | TourGuide™ Steerable Sheath | OSCOR INC. |
| 38 | 00850232006093 | TG0854517 | TG0854517 | Steerable Sheath, 8.5F | TourGuide™ Steerable Sheath | OSCOR INC. |
| 39 | 00850232006086 | TG0705517 | TG0705517 | Steerable Sheath, 7F | TourGuide™ Steerable Sheath | OSCOR INC. |
| 40 | 00850232006079 | TG0705509 | TG0705509 | Steerable Sheath, 7F | TourGuide™ Steerable Sheath | OSCOR INC. |
| 41 | 00850232006062 | TG0704517 | TG0704517 | Steerable Sheath, 7F | TourGuide™ Steerable Sheath | OSCOR INC. |
| 42 | 00850232006055 | TG0704509 | TG0704509 | Steerable Sheath, 7F | TourGuide™ Steerable Sheath | OSCOR INC. |
| 43 | 00850232006048 | TG0655517 | TG0655517 | Steerable Sheath, 6.5F | TourGuide™ Steerable Sheath | OSCOR INC. |
| 44 | 00850232006031 | TG0655509 | TG0655509 | Steerable Sheath, 6.5F | TourGuide™ Steerable Sheath | OSCOR INC. |
| 45 | 00850232006024 | TG0654517 | TG0654517 | Steerable Sheath, 6.5F | TourGuide™ Steerable Sheath | OSCOR INC. |
| 46 | 00850232006017 | TG0654509 | TG0654509 | Steerable Sheath, 6.5F | TourGuide™ Steerable Sheath | OSCOR INC. |
| 47 | 00850027837611 | 900309 | AcQCross Qx Integrated Transseptal Dilator/Needle | ACUTUS MEDICAL, INC. | ||
| 48 | 00850027837598 | 900308 | AcQCross Qx Integrated Transseptal Dilator/Needle | ACUTUS MEDICAL, INC. | ||
| 49 | 00850027837574 | 900307 | AcQCross Qx Integrated Transseptal Dilator/Needle | ACUTUS MEDICAL, INC. | ||
| 50 | 00850027837550 | 900306 | AcQCross Qx Integrated Transseptal Dilator/Needle | ACUTUS MEDICAL, INC. |