| 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 | 00884838071001 | L50 | 714248 | Philips MicroDose SI (Model: L50) is intended to produce radiographic images of Philips MicroDose SI (Model: L50) is intended to produce radiographic images of the human breast for the purpose of diagnostic and screening mammography. The system is intended to be used in the same clinical applications as traditional film-based mammography systems. | MicroDose SI | PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB |
| 2 | 00884838070943 | L50 | 714048 | Philips MicroDose Mammography SI L50 is intended to produce radiographic images Philips MicroDose Mammography SI L50 is intended to produce radiographic images of the human breast for the purpose of diagnostic and screening mammography. The system is intended to be used in the same clinical applications as traditional film-based mammography systems. | MicroDose SI | PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB |
| 3 | 00840682146845 | PRISTINA 2.0 | Software Pristina Infinity | not applicable | GE MEDICAL SYSTEMS | |
| 4 | 00840682145879 | EKB3 | Senographe Pristina | GE MEDICAL SYSTEMS | ||
| 5 | 00840682145862 | PRISTINA 0.0A | not applicable | GE MEDICAL SYSTEMS | ||
| 6 | 00840682143516 | PRISTINA 0.0 | not applicable | GE MEDICAL SYSTEMS | ||
| 7 | 00840682143486 | SIM1 | Sample Imaging | GE MEDICAL SYSTEMS | ||
| 8 | 00840682143424 | BSP1 | Breast Spacer | GE MEDICAL SYSTEMS | ||
| 9 | 00840682142373 | PRISTINA 0.1 | not applicable | GE MEDICAL SYSTEMS | ||
| 10 | 00840682142052 | EKB2 | Senographe Pristina | GE MEDICAL SYSTEMS | ||
| 11 | 00840682139397 | JMM1 | Horizontal | GE MEDICAL SYSTEMS | ||
| 12 | 00840682139229 | KAS1 | Pristina Serena | GE MEDICAL SYSTEMS | ||
| 13 | 00840682125802 | M3-2 | not applicable | GE MEDICAL SYSTEMS | ||
| 14 | 00840682123242 | ES14 | Senographe Essential | GE MEDICAL SYSTEMS | ||
| 15 | 00840682122603 | 5727669 | not applicable | GE MEDICAL SYSTEMS | ||
| 16 | 00840682121064 | GPE1 | SenoBright | GE MEDICAL SYSTEMS | ||
| 17 | 00840682118460 | EKB1 | Senographe Pristina | GE MEDICAL SYSTEMS | ||
| 18 | 00840682117852 | Accelera V5 | NA | GE MEDICAL SYSTEMS | ||
| 19 | 00195278347596 | KAS2 | Biopsy Option | Pristina Serena | GE MEDICAL SYSTEMS | |
| 20 | 00195278276971 | EKB6 | Senographe Pristina Core System | Senographe Pristina | GE MEDICAL SYSTEMS | |
| 21 | 00195278223937 | EKB5 | Senographe Pristina Core System | Senographe Pristina | GE MEDICAL SYSTEMS | |
| 22 | 00195278022745 | EKB4 | Senographe Pristina Core System | Senographe Pristina | GE MEDICAL SYSTEMS | |
| 23 | 00195278009289 | PRISTINA 0.0B | not applicable | GE MEDICAL SYSTEMS | ||
| 24 | 60889978869848 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | 8869844 | 24X30CM CR MAMMO SCR EHR-M3 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | CARESTREAM HEALTH, INC. |
| 25 | 60889978611614 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8611618 | 24X30CM DV REPLCMT PLATE/EHR-M2 SCR | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. |
| 26 | 60889978463329 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8463325 | 18X24CM DV REPLCMT PLATE/EHR-M2 SCR | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. |
| 27 | 60889978364763 | DIRECTVIEW CR Mammography Cassette with HR Screen | 8364762 | DIRECTVIEW CR Mammo Cassett HR Scrn18x24 | DIRECTVIEW CR Mammography Cassette with HR Screen | CARESTREAM HEALTH, INC. |
| 28 | 60889978359158 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8359150 | 24X30CM DVIEW CR MAMMO SCR EHR-M2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. |
| 29 | 60889978346134 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8346132 | 24X30CM DVIEW CR MAMMO SCR EHR-M | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. |
| 30 | 60889978215201 | CARESTREAM CR Mammography Cassette with SNP-M1 Screen | 8215204 | 24X30 CR MAMMO CASS W/SNP-M1 SCREEN | CARESTREAM CR Mammography Cassette with SNP-M1 Screen | CARESTREAM HEALTH, INC. |
| 31 | 60889971978608 | CARESTREAM CR Mammography Cassette with SNP-M1 Screen | 1978600 | CARESTREAM CR Cassette 35x43 / 14x17 | CARESTREAM CR Mammography Cassette with SNP-M1 Screen | CARESTREAM HEALTH, INC. |
| 32 | 60889971717443 | DIRECTVIEW CR Mammography Cassette with HR Screen | 1717446 | 10SC 18X24CM ESCN HR PHOSPHOR SCR | DIRECTVIEW CR Mammography Cassette with HR Screen | CARESTREAM HEALTH, INC. |
| 33 | 60889971650511 | DIRECTVIEW CR Mammography Cassette with HR Screen | 1650514 | DIRECTVIEW CR Cassett with HR Scrn 24x30 | DIRECTVIEW CR Mammography Cassette with HR Screen | CARESTREAM HEALTH, INC. |
| 34 | 60889971044297 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | 1044296 | CRMAMMO CASSETTE W/EHR M3 SCREEN 24X30 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | CARESTREAM HEALTH, INC. |
| 35 | 40889978792128 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8792129 | DIRECTVW CR Mammo Cass EHR-M Scrn 24x30 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. |
| 36 | 40889978336193 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | 8336190 | 18X24CM CR MAMMO SCR EHR-M3 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | CARESTREAM HEALTH, INC. |
| 37 | 40889978188341 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8188344 | 18X24CM DVIEW CR MAMMO SCR EHR-M | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. |
| 38 | 40889978156180 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | 8156184 | DIRECTVW CR Mammo Cass EHR-M3 Scrn 24x30 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | CARESTREAM HEALTH, INC. |
| 39 | 40889971941509 | CARESTREAM CR Mammography Cassette with SNP-M1 Screen | 1941509 | 18X24 CR MAMMO CASS W/SNP-M1 SCREEN | CARESTREAM CR Mammography Cassette with SNP-M1 Screen | CARESTREAM HEALTH, INC. |
| 40 | 40889971790312 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | 1790310 | DIRECTVW CR Mammo Cass EHR-M3 Scrn 18X24 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | CARESTREAM HEALTH, INC. |
| 41 | 40889971667577 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 1667575 | DIRECTVW CR Mammo Cass EHR-M2 Scrn 24x30 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. |
| 42 | 40889971508276 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 1508274 | DIRECTVW CR Mammo Cass EHR-M Scrn 18x24 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. |
| 43 | 40889971342863 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 1342864 | 18X24CM DVIEW CR MAMMO SCR EHR-M2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. |
| 44 | 40889971290386 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 1290386 | DIRECTVW CR Mammo Cass EHR-M2 Scrn 18x24 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. |
| 45 | 25420045512358 | ASY-13532 | ASY-13532 | Selenia Dimensions | HOLOGIC, INC. | |
| 46 | 25420045512341 | ASY-11738 | ASY-11738 | Selenia Dimensions | HOLOGIC, INC. | |
| 47 | 25420045512334 | ASY-11739 | ASY-11739 | Selenia Dimensions | HOLOGIC, INC. | |
| 48 | 15420045514713 | ASY-04160 | ASY-04160 | Selenia Dimensions | HOLOGIC, INC. | |
| 49 | 15420045514706 | RM-ASY-04160 | RM-ASY-04160 | Selenia Dimensions | HOLOGIC, INC. | |
| 50 | 15420045512665 | I-View 2.0 Software | I-View | HOLOGIC, INC. |