| 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 | 00869497000128 | CivaDerm | P-0296 | CivaDerm | CIVATECH ONCOLOGY, INC. | |
| 2 | 00869497000111 | CivaSheet | CivaSheet | CIVATECH ONCOLOGY, INC. | ||
| 3 | 00869497000104 | CivaString | CivaString | CIVATECH ONCOLOGY, INC. | ||
| 4 | 00863593000228 | F-01-01-0011 | The SIRIUS MRI Marker NS is a component device indicated as an accessory for use The SIRIUS MRI Marker NS is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy. | Sirius MRI Marker NS | C4 IMAGING, LLC | |
| 5 | 00863593000211 | F-01-01-0001 | F-01-01-0001 | The SIRIUS MRI Marker is a component device indicated as an accessory for use in The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carriersleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103(103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmedprostatic malignancy. | Sirius MRI Marker | C4 IMAGING, LLC |
| 6 | 00863593000204 | C-01-99-0014 | F-01-01-0001 | The SIRIUS MRI Marker is a component device indicated as an accessory for use in The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy. | Sirius MRI Marker | C4 IMAGING, LLC |
| 7 | 00860000064507 | GT-001 | Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a puri Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier | GammaTile™ | GT MEDICAL TECHNOLOGIES, INC. | |
| 8 | 00858589006063 | 67-6505 | 67-6505 | Cs-137, 12.5 mCi, sealed source | Cs-137 Tube Source | ECKERT & ZIEGLER ISOTOPE PRODUCTS, INC. |
| 9 | 00858589006056 | 67-6525 | 67-6525 | Cs-137, 62.5 mCi, sealed source | Cs-137 Tube Source | ECKERT & ZIEGLER ISOTOPE PRODUCTS, INC. |
| 10 | 00858589006049 | 67-6520 | 67-6520 | Cs-137, 50 mCi, sealed source | Cs-137 Tube Source | ECKERT & ZIEGLER ISOTOPE PRODUCTS, INC. |
| 11 | 00858589006032 | 67-6515 | 67-6515 | Cs-137, 37.5 mCi, sealed source | Cs-137 Tube Source | ECKERT & ZIEGLER ISOTOPE PRODUCTS, INC. |
| 12 | 00858589006025 | 67-6510 | 67-6510 | Cs-137, 25 mCi, sealed source | Cs-137 Tube Source | ECKERT & ZIEGLER ISOTOPE PRODUCTS, INC. |
| 13 | 00858589006018 | 67-6525 | 67-6525 | Cs-137, 62.5 mCi, sealed source | Cs-137 Tube Source | ECKERT & ZIEGLER ISOTOPE PRODUCTS, INC. |
| 14 | 00858589006001 | 67-6525 | 67-6525 | Cs-137 62.5 mCi, sealed source | Cs-137 Tube Source | ECKERT & ZIEGLER ISOTOPE PRODUCTS, INC. |
| 15 | 00853162006607 | L08320SM | 20, Loose 0.8 mm x 3 mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 16 | 00853162006584 | L1251SM | 1, Loose 1.2mm x 5mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 17 | 00853162006577 | 083312SM | 3, 18 ga x 12 cm needles, each containing 1, 0.8 x 3.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 18 | 00853162006560 | L08325SM | 25, Loose 0.8 mm x 3 mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 19 | 00853162006553 | 10104SM | 4, 18 ga x 20 cm needles, each needle containing one 1.0 x 10.0 mm gold marker, Sterile | Stellar Medical | STELLAR MEDICAL, LLC | |
| 20 | 00853162006546 | 1210430SM | 4, 17 ga x 30 cm needles, each needle containing one 1.2 x 10.0 mm gold marker, Sterile | Stellar Medical | STELLAR MEDICAL, LLC | |
| 21 | 00853162006539 | 12104SM | 4, 17 ga x 20 cm needles, each containing 1, 1.2 x 10.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 22 | 00853162006522 | 123430SM | 4, 17 ga x 30 cm needles, each containing 1, 1.2 x 3.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 23 | 00853162006515 | L1035SM | 5, Loose 1.0mm x 3mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 24 | 00853162006508 | L1055SM | 5, Loose 1.0mm x 5mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 25 | 00853162006492 | L08530SM | 30, Loose 0.8mm x 5mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 26 | 00853162006485 | 12103SM | 3, 17 ga x 20 cm needles, each needle containing one 1.2 x 10mm gold marker, Sterile | Stellar Medical | STELLAR MEDICAL, LLC | |
| 27 | 00853162006478 | 1210330SM | 3, 17 ga x 30 cm needles, each needle containing one 1.2 x 10.0 mm gold marker, Sterile | Stellar Medical | STELLAR MEDICAL, LLC | |
| 28 | 00853162006461 | L1053SM | 3, Loose 1.0mm x 5mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 29 | 00853162006454 | L0454SM | 4, Loose 0.4 mm x 5 mm Gold Markers in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 30 | 00853162006447 | 1210230SM | 2, 17 ga x 30 cm needles, each containing 1, 1.2 x 10.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 31 | 00853162006430 | 12102SM | 2, 17 ga x 20 cm needles, each containing 1, 1.2 x 10.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 32 | 00853162006423 | 1251SM | 1, 17 ga x 20 cm needle, containing 1, 1.2 x 5.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 33 | 00853162006416 | NA-1820SQ-NWS | 1, Needle App 18ga x 20cm Brachytherapy Non-Waxed, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 34 | 00853162006409 | L1034SM | 4, Loose 1.0mm x 3mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 35 | 00853162006393 | L1033SM | 3, Loose 1.0mm x 3mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 36 | 00853162006386 | L0855SM | 5, Loose 0.8mm x 5mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 37 | 00853162006379 | L0835SM | 5, Loose 0.8 mm x 3 mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 38 | 00853162006362 | L0834SM | 4, Loose 0.8 mm x 3 mm Gold Markers in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 39 | 00853162006355 | L0833SM | 3, Loose 0.8 mm x 3 mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 40 | 00853162006348 | L0832SM | 2, Loose 0.8 mm x 3 mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 41 | 00853162006331 | L0831SM | 1, Loose 0.8 mm x 3 mm Gold Marker in Vial, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 42 | 00853162006324 | 1255SM | 5, 17 ga x 20 cm needles, each containing 1, 1.2 x 5.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 43 | 00853162006317 | 1254SM | 4, 17 ga x 20 cm needles, each containing 1, 1.2 x 5.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 44 | 00853162006300 | 1253SM | 3, 17 ga x 20 cm needles, each containing 1, 1.2 x 5.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 45 | 00853162006294 | 1235SM | 5, 17 ga x 20 cm needles, each containing 1, 1.2 x 3.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 46 | 00853162006287 | 1234SM | 4, 17 ga x 20 cm needles, each containing 1, 1.2 x 3.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 47 | 00853162006270 | 1233SM | 3, 17 ga x 20 cm needles, each containing 1, 1.2 x 3.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 48 | 00853162006263 | 123330SM | 3, 17 ga x 30 cm needles, each containing 1, 1.2 x 3.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 49 | 00853162006256 | 1231SM | 1, 17 ga x 20 cm needles, containing 1, 1.2 x 3.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC | |
| 50 | 00853162006249 | 123130SM | 1, 17 ga x 30 cm needle, containing 1, 1.2 x 3.0 mm gold marker, St | Stellar Medical | STELLAR MEDICAL, LLC |