No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 15420045515031 | 2050-0104 | 2050-0104 | MWP | Cabinet, x-ray system | 2 | FAXITRON PATH | |
2 | 15420045514089 | R15 | R15 | GDF | GUIDE, NEEDLE, SURGICAL | 1 | PERL | |
3 | 15420045506909 | Discovery C | KGI | Densitometer, bone | 2 | Discovey C | ||
4 | 15420045504110 | ATEC Sapphire 200 | KNW | INSTRUMENT, BIOPSY | 2 | ATEC Sapphire 200 | ||
5 | 15420045510333 | 50-250XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MYOSURE XL HYSTEROSCOPY SET | ||
6 | 15420045514294 | V5 | NSV5US-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
7 | 25420045510330 | 50-250XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MYOSURE XL HYSTEROSCOPY SET | ||
8 | 25420045514307 | V5 | NSV5KITUS-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
9 | 25420045505107 | 40-902 | 40-902 | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MyoSure Tissue Removal Device | |
10 | 15420045514836 | PATHVISION 23x29 | PATHVISION23X29 | MWP | Cabinet, x-ray system | 2 | FAXITRON PATH | |
11 | 15420045514300 | V5 | NSV5KITUS-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
12 | 15420045512924 | INTERNAL CONTROL-B, 960T, IVD | PRD-06234 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | Panther Fusion | |
13 | 15420045512917 | EXTRACTION REAGENTS-B, 960T, IVD | PRD-06232 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | Panther Fusion | |
14 | 15420045510906 | GBS CTRLS KIT, PANTHER FUSION, IVD | PRD-04485 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
15 | 15420045510890 | GBS KIT, 96T, IVD | PRD-04484 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
16 | 15420045510470 | INTERNAL CONTROL-X, 960T, IVD | PRD-04476 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
17 | 15420045510463 | EXTRACTION REAGENT-X, 960T, IVD | PRD-04477 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
18 | 15420045509641 | System Software | InSight FD | OXO | Image-intensified fluoroscopic x-ray system, mobile | 2 | Flouroscan InSight | |
19 | 15420045509375 | CLASS I CONTROL - C. ALBICANS | PRD-04521 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | aptima | |
20 | 15420045507937 | 20-401ML | 20-401ML | NWW | Hysteroscope accessories | Myosure Manual Tissue Removal Device | ||
21 | 15420045505230 | B90003 | B90003 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | 4.0-5.0 CM CT LUMEN MARKER SET | |
22 | 15420045505193 | B11245 | B11245 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | 4-5 CM CONTURAFLEX MLB CATHETER w/TRI INTRODUCER | |
23 | 15420045505094 | 50-501XL | 50-501XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
24 | 15420045505087 | 50-401XL | 50-401XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MyoSure Tissue Removal Device | |
25 | 15420045505070 | 30-401LITE | 30-401LITE | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
26 | 15420045505001 | 919007-01 | 919007-01 | JAQ | System, applicator, radionuclide, remote-controlled | Mammosite Variable 4-5 cm Applicator Tray | ||
27 | 15420045504998 | EVIVA_1213-20 | EVIVA_1213-20 | KNW | INSTRUMENT, BIOPSY | EVIVA_1213-20 | ||
28 | 15420045504950 | EVIVA_0910-20 | EVIVA_0910-20 | KNW | INSTRUMENT, BIOPSY | EVIVA_0910-20 | ||
29 | 15420045504813 | 10-401 | 10-401 | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
30 | 15420045501140 | 2000 | NS2000US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure | ||
31 | 15420045501133 | 2007 | NS2007US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure SureSound | ||
32 | 15420045501126 | 2013 | NS2013KITUS | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure SureSound | ||
33 | 15420045501119 | 2013 | NS2013US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure | ||
34 | 15420045501065 | Cervista HTA System Computer | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
35 | 15420045500969 | Cervista HTA System | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
36 | 15420045500952 | Cervista HTA System | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
37 | 15420045500860 | NovaSure Controller | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | 3 | NovaSure | ||
38 | 15420045500853 | NovaSure Controller | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | 3 | NovaSure | ||
39 | 15420045512474 | GENIUS AI DETECTION SOFTWARE | OTE | Digital breast tomosynthesis | 3 | GENIUS AI DETECTION | ||
40 | 25420045510064 | FILTER, THINPREP UROCYTE 100 PACK | 70472-001 | KET | FILTERS, CELL COLLECTION, TISSUE PROCESSING | ThinPrep | ||
41 | 25420045510057 | THINPREP SLIDES UROCYTE, 100 pk | 70471-001 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
42 | 25420045509990 | THINPREP MICROSCOPE, ARCLESS, 72pk | 70126-002 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
43 | 25420045509679 | NON-GYN Slides | 70372-001 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
44 | 25420045509662 | NON-GYN Filters, 100 pack | 70205-001 | KET | FILTERS, CELL COLLECTION, TISSUE PROCESSING | ThinPrep | ||
45 | 25420045508467 | UroCyte Vial | 70473-001 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
46 | 25420045505039 | 819001 | 819001 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Neucletron HDR Afterloader Connectors wObturators | |
47 | 15420045514775 | PRESERVCYT VIAL | PRD-07129 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
48 | 15420045514621 | UroCyte Vial | ASY-15509 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
49 | 15420045514614 | CytoLyt Cup | PRD-07065 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
50 | 15420045514607 | CytoLyt Tube | PRD-07064 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00815137021251 | 311S | Protective Coverlets for Mammography - 29.2cm x 33.0cm | Bella Blankets | BEEKLEY CORPORATION | |
2 | 00815137021244 | 310S | Protective Coverlets for Mammography - 22.9cm x 27.9cm | Bella Blankets | BEEKLEY CORPORATION | |
3 | 00815137020247 | 311 | Protective Coverlets for Mammography - 29.2cm x 33.0cm | Bella Blankets | BEEKLEY CORPORATION | |
4 | 00815137020230 | 310 | Protective Coverlets for Mammography - 22.9cm x 27.9cm | Bella Blankets | BEEKLEY CORPORATION | |
5 | 00813079020424 | LNGO-2022 | LNGO-2022 | 20/22ga (0.9/0.7mm) | Open Needle Guide | REMINGTON MEDICAL, INC. |
6 | 00813079020417 | LNGC-2022 | LNGC-2022 | 20/22ga (0.9/0.7mm) | Closed Needle Guide | REMINGTON MEDICAL, INC. |
7 | 00813079020400 | LNGC-14 | LNGC-14 | 14ga (2.1mm) | Closed Needle Guide | REMINGTON MEDICAL, INC. |
8 | B852SPECBOARD4440 | 444 | Device Classification Name System, X-Ray, Mammographic510(K) Number K891090 | Specboard | MACBRUD CORPORATION | |
9 | B852SPECBOARD2220 | 222 | Device Classification Name System, X-Ray, Mammographic510(K) Number K123414Devic Device Classification Name System, X-Ray, Mammographic510(K) Number K123414Device Name SPECBOARD JR. | SPECBOARD JR | MACBRUD CORPORATION | |
10 | 45420045505811 | MP301-T | MP301-T | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
11 | 45420045505804 | MP301-D | MP301-D | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
12 | 45420045505798 | MP301 | MP301 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
13 | 45420045505781 | MP201 | MP201 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
14 | 45420045505668 | MP101 | MP101 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
15 | 30382904094097 | 409409 | 409409 | NEEDLE BIOPSY S/SU 20GA 1-1/2IN BREAST | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY |
16 | 30382904094080 | 409408 | 409408 | NEEDLE BIOPSY S/SU 20GA 2-1/2IN BREAST | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY |
17 | 30382904094073 | 409407 | 409407 | NEEDLE BIOPSY S/SU 20GA 3-1/2IN BREAST | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY |
18 | 25420045507347 | MP201-10 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | ||
19 | 25420045507330 | MP301-10 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | ||
20 | 25420045506951 | MP301-T | MP301-T | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
21 | 25420045506944 | MP301-D | MP301-D | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
22 | 15420045512948 | AFFIRM™ CONTRAST BIOPSY SOFTWARE | AFFIRM™ CONTRAST BIOPSY | HOLOGIC, INC. | ||
23 | 15420045512931 | AFFIRM™ SPECIMEN IMAGING | AFFIRM™ SPECIMEN IMAGING | HOLOGIC, INC. | ||
24 | 15420045510869 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
25 | 15420045510852 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
26 | 15420045510845 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
27 | 15420045507197 | ASY-03669 | ASY-03669 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
28 | 15420045507180 | ASY-03668 | ASY-03668 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
29 | 15420045507173 | ASY-03667 | ASY-03667 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
30 | 15420045506831 | ASY-05205 | ASY-05205 | Affirm Lateral Arm Upright Biopsy Accessory | HOLOGIC, INC. | |
31 | 15420045506824 | ASY-09644 | ASY-09644 | Affirm Lateral Arm Upright Biopsy Accessory | HOLOGIC, INC. | |
32 | 15420045506817 | ASY-03723 | ASY-03723 | Affirm Lateral Arm Upright Biopsy Accessory | HOLOGIC, INC. | |
33 | 15420045506541 | ASY-09175 | ASY-09175 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
34 | 15420045506534 | ASY-08832 | ASY-08832 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
35 | 15420045506527 | ASY-06886 | ASY-06886 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
36 | 15420045506510 | PBX-SYS-AFFIRM-3D | PBX-SYS-AFFIRM-3D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
37 | 15420045506503 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
38 | 15420045506497 | ASY-08178 | ASY-08178 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
39 | 15420045506480 | ASY-08176 | ASY-08176 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
40 | 15420045506473 | ASY-08175 | ASY-08175 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
41 | 15420045506466 | ASY-08174 | ASY-08174 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
42 | 15420045506077 | 3-000-2247 | 3-000-2247 | Digital Spot Mammography System, DSM | HOLOGIC, INC. | |
43 | 15420045505926 | 8-004-0017 | 8-004-0017 | Multicare Platinum | HOLOGIC, INC. | |
44 | 15420045505858 | STLC-00004 | STLC-00004 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
45 | 15420045504738 | 3D System Software | Affirm Prone Biopsy System | HOLOGIC, INC. | ||
46 | 15420045504721 | System Software | Affirm Prone Biopsy System | HOLOGIC, INC. | ||
47 | 08033837190301 | MAMMOBED | 6100-06M1 | It's a special table on wheels for stereotactic breast biopsy procedures with pa It's a special table on wheels for stereotactic breast biopsy procedures with patient in prone position. | MAMMOBED | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |
48 | 08033837190219 | BIOPSY DIGIT AM | 9100-01 | Biopsy Digit device uses two stereo images taken by a digital solid state camera Biopsy Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. It is intended to mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement. | BIOPSY DIGIT | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |
49 | 08033837190202 | BIOPSY DIGIT SL | 9201-01 | Biopsy Digit SL is a medical device intended to be used for mamnmographic proced Biopsy Digit SL is a medical device intended to be used for mamnmographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement. | BIOPSY DIGIT | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |
50 | 08033837190110 | GIOTTO IMAGE SRA | 6702 | Giotto Image is a conventional film-screen x-ray mammographic device. | GIOTTO IMAGE | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |