| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 08717213034129 | 137279-00 | Applicator Mask Straps | JAQ | System, applicator, radionuclide, remote-controlled | NA | ||
| 2 | 08717213024120 | 137416P01-02 | Intravaginal Tube, Ti | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 3 | 08717213008915 | 084457-00 | Intrauterine Tube, angle 30° | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 4 | 08717213036581 | 080026P01-00 | microSelectron Adapter for 6F catheters | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 5 | 08717213032286 | 083058P01-00 | Trocar Needle Ø1.9 mm x 160 mm | JAQ | System, applicator, radionuclide, remote-controlled | NA | ||
| 6 | 08717213042162 | 085119P01-00 | Cap, Ø 30 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 7 | 08717213042155 | 085118P01-00 | Cap, Ø 20 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 8 | 08717213034556 | 189740-06 | Ovoid Tube 2 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 9 | 08717213034549 | 189740P01-06 | Ovoid Tube 2 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 10 | 08717213042148 | 085117P01-00 | Cap, Ø 10 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 11 | 08717213056961 | 131055A02-07 | Oncentra Prostate Laptop Cart | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 12 | 08717213056954 | 131055A01-07 | Oncentra Prostate Laptop Cart | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 13 | 08717213056947 | 189714P01-03 | INSERTION TOOL | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | NA | |
| 14 | 08717213053717 | 170538-00 | Oncentra External Beam 4.5.3/Oncentra Brachy v4.6 | MUJ | System, planning, radiation therapy treatment | 2 | NA | |
| 15 | 08717213053700 | 170018-00 | Oncentra External Beam 4.5.3/Oncentra Brachy v4.6 | MUJ | System, planning, radiation therapy treatment | NA | ||
| 16 | 08717213053151 | 101003P01-07 | Intrauterine Tube CT/MR 15°, 40 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 17 | 08717213053137 | 101002P01-07 | Vaginal Tube | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 18 | 08717213053113 | 101005P01-07 | Intrauterine Tube CT/MR 45°, 80 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 19 | 08717213053069 | 101004P01-07 | Intrauterine Tube CT/MR 30°, 60 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 20 | 08717213052895 | 130512P01-01 | Needle Template B&K 18 G for LDR | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 21 | 08717213052826 | 130512C-00 | Adjusting Ring | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 22 | 08717213052789 | 189367P01-01 | Flexible Implant Tube Cutter | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 23 | 08717213052758 | 170607-00 | Oncentra External Beam Oncentra Brachy v4.6.1 | MUJ | System, planning, radiation therapy treatment | 2 | NA | |
| 24 | 08717213052710 | 110957P01-01 | Fixation Clip | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Fletcher CT/MR Shielded Applicator | |
| 25 | 08717213052666 | 101160-03 | Threaded End | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 26 | 08717213052659 | 110958-00 | Clip Part 1 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Fletcher CT/MR Shielded Applicator | |
| 27 | 08717213052642 | 110959-00 | Clip Part 2 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Fletcher CT/MR Shielded Applicator | |
| 28 | 08717213052321 | 170537-08 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 29 | 08717213052314 | 170003-28 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 30 | 08717213052307 | 170537-06 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 31 | 08717213052291 | 170003-27 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 32 | 08717213052246 | 170537-06 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 33 | 08717213052239 | 170003-25 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 34 | 08717213051881 | 170537-05 | Oncentra External Beam/Oncentra Brachy v4.5.2 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 35 | 08717213051843 | 170003-24 | Oncentra External Beam/Oncentra Brachy v4.5.2 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 36 | 08717213051799 | 089013P02-00 | Obturator for 1.5mm Needle x 200mm | JAQ | System, applicator, radionuclide, remote-controlled | NA | ||
| 37 | 08717213051782 | 170537-04 | Oncentra External Beam/Oncentra Brachy v4.5.2 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 38 | 08717213051775 | 170003-23 | Oncentra External Beam/Oncentra Brachy v4.5.2 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 39 | 08717213034532 | 189735-06 | Ovoid Tube 1 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 40 | 08717213051584 | 083926P02-00 | Trocar Needle 1.5mm x 200mm | JAQ | System, applicator, radionuclide, remote-controlled | NA | ||
| 41 | 08717213051379 | 189731P01-01 | Screw Pin | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 42 | 08717213051362 | 189727P01-01 | Fixation Clip Screw | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 43 | 08717213051294 | 170730 | Oncentra External Beam/Oncentra Brachy v4.5.2 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 44 | 08717213051270 | 089701P01-00 | Leader Insertion Needle, 1.5 x 160 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 45 | 08717213051263 | 089700P02-00 | Leader Insertion Needles, 1.5 x 120 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 46 | 08717213051140 | 106990 | microSelectron Digital | JAQ | System, applicator, radionuclide, remote-controlled | 2 | microSelectron Digital | |
| 47 | 08717213050945 | 111683P01-01 | Flexitron Transfer Tube GYN SS (G5-3) | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 48 | 08717213050938 | 111009P01-03 | microSelectron Transfer Tube CT/MR GYN (3) | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 49 | 08717213050860 | 084050P01-02 | Ring Applicator Set, Additional Items | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 50 | 08717213050853 | 110669P01-00 | Ring CT/MR Applicator Set 4mm, Additional Items | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | M748PL80 | PL-8 | The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-8 device is preloaded strands with Markers in 18G needles. | PL-8 Cs-131 Brachytherapy Seeds Preloaded Strands in 18G Needles with MRI Marker | ISORAY MEDICAL, INC. | |
| 2 | M748PL70 | PL-7 | The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-7 device is preloaded strands with Markers. | PL-7 Cs-131 Brachytherapy Seeds in Preloaded Strands with MRI Markers | ISORAY MEDICAL, INC. | |
| 3 | M748PL5M0 | PL-5M | Proxcelan™ Cs-131 Preloaded Braided Strands | ISORAY MEDICAL, INC. | ||
| 4 | M748PL50 | PL-5 | Proxcelan™ Cs-131 Preloaded Braided Strands | ISORAY MEDICAL, INC. | ||
| 5 | M748PL4NS0 | PL-4NS | Proxcelan™ Cs-131 Preloaded Mick® Cartridges - Non Sterile | ISORAY MEDICAL, INC. | ||
| 6 | M748PL40 | PL-4 | Proxcelan™ Cs-131 Preloaded S-Cartridges | ISORAY MEDICAL, INC. | ||
| 7 | M748PL30 | PL-3 | Proxcelan™ Cs-131 Preloaded 18G Needles | ISORAY MEDICAL, INC. | ||
| 8 | M748PL20 | PL-2 | Proxcelan™ Cs-131 Preloaded Strands in 18G Needles | ISORAY MEDICAL, INC. | ||
| 9 | M748PL10 | PL-1 | Proxcelan™ Cs-131 Strands | ISORAY MEDICAL, INC. | ||
| 10 | M748CS1NS0 | CS-1NS | Proxcelan™ Cs-131 Brachytherapy Seeds | ISORAY MEDICAL, INC. | ||
| 11 | M748CS10 | CS-1 | Proxcelan™ Cs-131 Brachytherapy Seeds | ISORAY MEDICAL, INC. | ||
| 12 | M74890050 | 9005 | GliaSite® Access Tray | ISORAY MEDICAL, INC. | ||
| 13 | M74881600 | 8160 | Cesitrex™ | ISORAY MEDICAL, INC. | ||
| 14 | M74881500 | 8150 | Iotrex® | ISORAY MEDICAL, INC. | ||
| 15 | M74810400 | 1040 | GliaSite® Catheter Tray | ISORAY MEDICAL, INC. | ||
| 16 | M74810300 | 1030 | GliaSite® Catheter Tray | ISORAY MEDICAL, INC. | ||
| 17 | M74810200 | 1020 | GliaSite® Catheter Tray | ISORAY MEDICAL, INC. | ||
| 18 | 10801741184137 | 7030550 | 7030550 | 5.0mm Spacer, Sterile Pack of 50 | SourceLink 5.0mm Spacer | BARD BRACHYTHERAPY, INC. |
| 19 | 10801741184120 | 7030450 | 7030450 | 5.5mm Spacer, Sterile Pack of 50 | SourceLink 5.5mm Spacer | BARD BRACHYTHERAPY, INC. |
| 20 | 10801741078153 | 7030310 | 7030310 | SourceLink™ 5.0mm Extension SourceLink™ - Model 7030310 Synthetic Absorbable See SourceLink™ 5.0mm Extension SourceLink™ - Model 7030310 Synthetic Absorbable Seeding Spacer Links, 10 ea | SourceLink™ 5.0mm Extension SourceLink™ | BARD BRACHYTHERAPY, INC. |
| 21 | 10801741078146 | 7030205 | 7030205 | SourceLink™ 0.5mm Seed-to-Seed SourceLink™ - Model 7030205 Synthetic Absorbable SourceLink™ 0.5mm Seed-to-Seed SourceLink™ - Model 7030205 Synthetic Absorbable Seeding Spacer Links, 5 ea | SourceLink™ 0.5mm Seed-to-Seed SourceLink™ | BARD BRACHYTHERAPY, INC. |
| 22 | 10801741078139 | 7030120 | 7030120 | SourceLink™ 5.5mm Standard SourceLink™ - Model 7030120 Synthetic Absorbable Seed SourceLink™ 5.5mm Standard SourceLink™ - Model 7030120 Synthetic Absorbable Seeding Spacer Links, 20 ea. | SourceLink™ 5.5mm Standard SourceLink™ | BARD BRACHYTHERAPY, INC. |
| 23 | 10801741078122 | SPCRQC20 | SPCRQC20 | QuickLink™ Cartridge 5.5mm CP Medical BioSpacer™ Synthetic Absorbable Seeding Sp QuickLink™ Cartridge 5.5mm CP Medical BioSpacer™ Synthetic Absorbable Seeding Spacer Links #20 | QuickLink™ Cartridge 5.5mm Spacer | BARD BRACHYTHERAPY, INC. |
| 24 | 10801741078115 | 70303QC20 | 70303QC20 | QuickLink™ Cartridge 5.0mm Extension SourceLink™ Synthetic Absorbable Seeding Sp QuickLink™ Cartridge 5.0mm Extension SourceLink™ Synthetic Absorbable Seeding Spacer Links #20 | QuickLink™ Cartridge 5.0mm Extension SourceLink™ | BARD BRACHYTHERAPY, INC. |
| 25 | 10801741078108 | 70303QC10 | 70303QC10 | QuickLink™ Cartridge 5.0mm Extension SourceLink™ Synthetic Absorbable Seeding Sp QuickLink™ Cartridge 5.0mm Extension SourceLink™ Synthetic Absorbable Seeding Spacer Links #10 | QuickLink™ Cartridge 5.0mm Extension SourceLink™ | BARD BRACHYTHERAPY, INC. |
| 26 | 10801741078092 | 70302QC10 | 70302QC10 | QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™ Synthetic Absorbable Seeding QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™ Synthetic Absorbable Seeding Spacer Links #10 | QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™ | BARD BRACHYTHERAPY, INC. |
| 27 | 10801741078085 | 70302QC5 | 70302QC5 | QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™ Synthetic Absorbable Seeding QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™ Synthetic Absorbable Seeding Spacer Links #5 | QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™ | BARD BRACHYTHERAPY, INC. |
| 28 | 10801741078078 | 70301QC20 | 70301QC20 | QuickLink™ Cartridge 5.5mm Standard SourceLink™ Synthetic Absorbable Seeding Spa QuickLink™ Cartridge 5.5mm Standard SourceLink™ Synthetic Absorbable Seeding Spacer Links #20 | QuickLink™ Cartridge 5.5mm Standard SourceLink™ | BARD BRACHYTHERAPY, INC. |
| 29 | 10801741078061 | 70301QC5 | 70301QC5 | QuickLink™ Cartridge 5.5mm Standard SourceLink™ Synthetic Absorbable Seeding Spa QuickLink™ Cartridge 5.5mm Standard SourceLink™ Synthetic Absorbable Seeding Spacer Links #5 | QuickLink™ Cartridge 5.5mm Standard SourceLink™ | BARD BRACHYTHERAPY, INC. |
| 30 | 10790986007038 | FN18-53T | FN NEEDLES | C.P. MEDICAL CORPORATION | ||
| 31 | 10790986006345 | FN17-1T | FN17-1T | FN NEEDLES | C.P. MEDICAL CORPORATION | |
| 32 | 10790986006338 | FN17-3T | FN17-3T | FN NEEDLES | C.P. MEDICAL CORPORATION | |
| 33 | 10790986006321 | FN17-51T | FN17-51T | FN NEEDLES | C.P. MEDICAL CORPORATION | |
| 34 | 10790986006314 | FN18-1T | FN18-1T | FN NEEDLES | C.P. MEDICAL CORPORATION | |
| 35 | 10790986006307 | FN18-3T | FN18-3T | FN NEEDLES | C.P. MEDICAL CORPORATION | |
| 36 | 10790986006291 | FN18-51T | FN18-51T | FN NEEDLES | C.P. MEDICAL CORPORATION | |
| 37 | 08717213037854 | 130002CAL-01 | 130002CAL | Non-sterile IODINE—125 source for use with seedSelectron® for system calibration Non-sterile IODINE—125 source for use with seedSelectron® for system calibration. Not for human use. | selectSeed™ I-125 | NUCLETRON B.V. |
| 38 | 04049223100780 | RU6.A033 | RU6.A033 | Ru-106 Eye Applicator, type CXS 4 MBq | ECKERT & ZIEGLER BEBIG GMBH | |
| 39 | 04049223100773 | RU6.A03 | RU6.A03 | Ru-106 Eye Applicator, type CCX 6 MBq | ECKERT & ZIEGLER BEBIG GMBH | |
| 40 | 04049223100766 | RU6.A02 | RU6.A02 | Ru-106 Eye Applicator, type CCY 6 MBq | ECKERT & ZIEGLER BEBIG GMBH | |
| 41 | 04049223100759 | RU6.A01 | RU6.A01 | Ru-106 Eye Applicator, type CCZ 6 MBq | ECKERT & ZIEGLER BEBIG GMBH | |
| 42 | 04049223117184 | I25.S17PLUS-ULH | Ophth. seeds, unsterile, loose, high activity | IsoSeed® I-125, unsterile, loose, high activity | ECKERT & ZIEGLER BEBIG GMBH | |
| 43 | 04049223104924 | AGD.A35 | AGD.A35 | Dummy, silver, type CIB-2 | ECKERT & ZIEGLER BEBIG GMBH | |
| 44 | 04049223104917 | AGD.A34 | AGD.A34 | Dummy, silver, type CIB | ECKERT & ZIEGLER BEBIG GMBH | |
| 45 | 04049223104900 | AGD.A33 | AGD.A33 | Dummy, silver, type CIA | ECKERT & ZIEGLER BEBIG GMBH | |
| 46 | 04049223104894 | AGD.A32 | AGD.A32 | Dummy, silver, type COC | ECKERT & ZIEGLER BEBIG GMBH | |
| 47 | 04049223104887 | AGD.A31 | AGD.A31 | Dummy, silver, type COE | ECKERT & ZIEGLER BEBIG GMBH | |
| 48 | 04049223104870 | AGD.A30 | AGD.A30 | Dummy, silver, type COD | ECKERT & ZIEGLER BEBIG GMBH | |
| 49 | 04049223104863 | AGD.A29 | AGD.A29 | Dummy, silver, type COB | ECKERT & ZIEGLER BEBIG GMBH | |
| 50 | 04049223104856 | AGD.A28 | AGD.A28 | Dummy, silver, type CCC | ECKERT & ZIEGLER BEBIG GMBH |