No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00813787021256 | XX772xL | Loose VariStrand with 1-9 seeds, standard spacing | KXK | Source, Brachytherapy, Radionuclide | 2 | VariStrand RT with TheraSeed | |
2 | 00813787021188 | XX772x | VariStrand with x = 1-12 seeds and 0 or more spacers | KXK | Source, Brachytherapy, Radionuclide | 2 | VariStrand with TheraSeed® | |
3 | 00813787022338 | TG7745i | TheraMark (Anchorseed with AgX100 - 5 cm) -STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | TheraMark™ | |
4 | 00813787022321 | TG7747i | TheraMark (Anchorseed with AgX100 - 7 cm) -STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | TheraMark™ | |
5 | 00813787022314 | TG745i | TheraMark (TheraStrand with AgX100 - 5 cm) - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | TheraMark™ | |
6 | 00813787022307 | TG747i | TheraMark (TheraStrand with AgX100 - 7 cm) - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | TheraMark™ | |
7 | 00813787022291 | TG445i | TheraMark (AgX100 loose seed - 5 cm ) - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | TheraMark™ | |
8 | 00813787022284 | TG447i | TheraMark (AgX100 loose seed - 7 cm ) - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | TheraMark™ | |
9 | 00813787022277 | TG77412i | TheraMark (TheraStrand with AgX100 -12 cm) - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | TheraMark™ | |
10 | 00813787022260 | TG7412i | TheraMark (TheraStrand with AgX100 -12 cm) - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | TheraMark™ | |
11 | 00813787022253 | TG4412i | TheraMark (AgX100 loose seed -12 cm ) - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | TheraMark™ | |
12 | 00813787021164 | XX782x | AnchorLoad with x = 1-12 seeds and 0 or more spacers | KXK | Source, Brachytherapy, Radionuclide | 2 | AnchorLoad with TheraSeed® | |
13 | 00813787021423 | CPPS-SQ-1820X-1 | IWJ | System, Applicator, Radionuclide, Manual | 1 | Theragenics | ||
14 | 00813787021331 | XX77315iF | AnchorSeed/TSL in FlatPack – 15 stranded seeds per mag– STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | AnchorSeed with I-Seed | |
15 | 00813787021324 | XX77315iN | AnchorSeed/TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | AnchorSeed with I-Seed | |
16 | 00813787021232 | ON772xi | VariStrand with OncoSeed, x = 1-12 seeds and 0 or more spacers | KXK | Source, Brachytherapy, Radionuclide | 2 | VariStrand with OncoSeed | |
17 | 00813787020938 | XX72x | TheraStrand with x = 1-12 seeds and 0 or more spacers for CN | KXK | Source, Brachytherapy, Radionuclide | 2 | TheraStrand® with TheraSeed® | |
18 | 00813787020921 | XX72xLN | Loose TheraStrand with 1-6 seeds, standard spacing, in TPSII Ind. for CN | KXK | Source, Brachytherapy, Radionuclide | 2 | TheraStrand® with TheraSeed® | |
19 | 00813787020914 | XX72xL | Loose TheraStrand with 1-6 seeds, standard spacing for CN | KXK | Source, Brachytherapy, Radionuclide | 2 | TheraStrand® with TheraSeed® | |
20 | 00813787020341 | XXmmNi | Notched Seed Carrier where “mm” = 10, 12, 14, 16, 18, 20, or 22mm | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
21 | 00813787020334 | XXmmCi | Circular Seed Carrier where “mm” = 10, 12, 14, 16, 18, 20, or 22mm | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
22 | 00813787020297 | XX1526i | Seeds for IsoStrand - STERILE | KPT | Calibrator, Dose, Radionuclide | 2 | I-Seed Agx100 | |
23 | 00813787020280 | XX1525i | Seeds for IsoCartridge - STERILE | KPT | Calibrator, Dose, Radionuclide | 2 | I-Seed Agx100 | |
24 | 00813787020273 | XX75xi | C20 in TPSII Single x = 10, 15 or 20 seeds per mag - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
25 | 00813787020266 | XX5057iN | C20 IsoLoader magazines in TPSII Ind. – 20 seeds per mag- STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
26 | 00813787020259 | XX5056iN | IsoLoader magazines in TPSII Ind. - 20 seeds per mag- STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
27 | 00813787020242 | XX5057i | C20 IsoLoader magazines in TPSII – 20 seeds per mag- STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
28 | 00813787020235 | XX5056i | IsoLoader magazines in TPSII - 20 seeds per mag- STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
29 | 00813787020228 | XX2057i | C20 IsoLoader magazines in TPSII – 20 seeds per mag | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
30 | 00813787020211 | XX2056i | IsoLoader magazines in TPSII - 20 seeds per mag | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
31 | 00813787020204 | XX1520iN | In-STANT magazines in TPSII Ind. - 20 seeds per mag - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
32 | 00813787020198 | XX1520i | In-STANT magazines in TPSII - 20 seeds per mag - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
33 | 00813787020181 | XX1220i | In-STANT magazines in TPSII - 20 seeds per mag | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
34 | 00813787020174 | XX65xiN | C20 in TPSII Ind. x = 10, 15 or 20 seeds per mag - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
35 | 00813787020167 | XX65xi | C20 in TPSII x = 10, 15 or 20 seeds per mag - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
36 | 00813787020150 | XX62xi | C20 in TPSII x = 10, 15 or 20 seeds per mag | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
37 | 00813787020143 | XX650xi | C20 in FlatPack x = (1)10, (3)15 or (7)20 seeds per mag - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
38 | 00813787020136 | XX620xi | C20 in FlatPack x = (1)10, (3)15 or (7)20 seeds per mag | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
39 | 00813787020129 | XX52xiN | VSM in TPSII Ind. x = 10, 15 or 20 seeds per mag - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
40 | 00813787020112 | XX52xi | VSM in TPSII x = 10, 15 or 20 seeds per mag - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
41 | 00813787020105 | XX22xi | VSM in TPSII x = 10, 15 or 20 seeds per mag | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
42 | 00813787020099 | XX50xiN | Mick magazines in TPSII Ind. x = (8)15, or (9)10 seeds per mag - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
43 | 00813787020082 | XX50xi | Mick magazines in TPS x = (8)15, or (9)10 seeds per mag - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
44 | 00813787020075 | XX20xi | Mick magazines in TPS x = (8)15, or (9)10 seeds per mag | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
45 | 00813787020068 | XX607i | High activity loose seeds for the Eye – STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
46 | 00813787020051 | XX307i | High activity loose seeds for the Eye | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
47 | 00813787020044 | XX400i | Loose seeds in a vial for 3rd party processing | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
48 | 00813787020037 | XX500i | Loose seeds in a vial - STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
49 | 00813787020020 | XX200i | Loose seeds in a vial | KXK | Source, Brachytherapy, Radionuclide | 2 | I-Seed Agx100 | |
50 | 00813787021317 | XX77315F | AnchorSeed/TSL in FlatPack – 15 stranded seeds per mag– STERILE | KXK | Source, Brachytherapy, Radionuclide | 2 | AnchorSeed with TheraSeed® |
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 |