| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00888118124074 | 60-500-40-09 | HWT | TEMPLATE | 1 | IPS | ||
| 2 | 00888118124036 | 07-005-54-07 | GZX | INSTRUMENT, MICROSURGICAL | 1 | DISSECTOR | ||
| 3 | 00888118123930 | 25-407-10-04 | HXX | SCREWDRIVER | 1 | L1 RECONGUIDE | ||
| 4 | 00888118123923 | 25-500-33-07 | HWT | TEMPLATE | 1 | L1 RECONGUIDE | ||
| 5 | 00888118123893 | 25-500-30-07 | HWT | TEMPLATE | 1 | L1 RECONGUIDE | ||
| 6 | 00888118123879 | 25-500-28-07 | HWT | TEMPLATE | 1 | L1 RECONGUIDE | ||
| 7 | 00888118124135 | 60-500-49-09 | HWT | TEMPLATE | 1 | IPS | ||
| 8 | 00888118123749 | 25-500-02-07 | HWT | TEMPLATE | 1 | L1 RECONGUIDE | ||
| 9 | 10888118127140 | 25-882-07-74 | SCREW, MAXDRIVE, TLTS, TI-6AL-4V | JEY | PLATE, BONE | 2 | LEVEL ONE CMF, STERILE | |
| 10 | 00888118124128 | 60-500-47-09 | HWT | TEMPLATE | 1 | IPS | ||
| 11 | 10888118130935 | 25-765-11-09 | SCREW, ONEDRIVE, TI-6AL-4V | JEY | PLATE, BONE | 2 | LEVEL ONE CMF | |
| 12 | 10888118097924 | 24-039-30-72 | PLATE, STERNAL, LSS, STR, 2.3 MM SCREW, PEEK | HRS,JDQ | Plate, fixation, bone,CERCLAGE, FIXATION | LEVEL ONE THORACIC, STERILE | ||
| 13 | 10888118054552 | 26-975-90-07 | HRS | Plate, fixation, bone | LEVEL ONE SMALL BONE | |||
| 14 | 10888118049268 | 26-014-17-09 | SCREW, SMARTDRIVE, LOCKING, TI-6AL-4V | HRS | Plate, fixation, bone | LEVEL ONE SMALL BONE | ||
| 15 | 10888118047387 | 25-875-06-09 | SCREW, MAXDRIVE, TI-6AL-4V | JEY | PLATE, BONE | LEVEL ONE CMF | ||
| 16 | 10888118044102 | 25-669-05-09 | SCREW, CENTREDRIVE, DRILL FREE, TI-6AL-4V | HRS | Plate, fixation, bone | LEVEL ONE CMF | ||
| 17 | 10888118004014 | 01-008-09-04 | HWT | TEMPLATE | LEVEL ONE CMF | |||
| 18 | 10888118001242 | 52-522-56-04 | SONICPIN RXG, PLLA-PGA | JEY | PLATE, BONE | SONICWELD RX, STERILE | ||
| 19 | 00888118129758 | 60-008-84-09 | DIST, ORAL/MAX, ZURICH 2, MID DRV, LARGE, CP TITANIUM | MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR | 2 | IPS | |
| 20 | 00888118129468 | 50-775-36-09 | PLATE, RECON PLUS, TLTS, ANGLE, RIGHT, 2.0-2.5 MM SCREW, CP TITANIUM | MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR | 2 | LEVEL ONE CMF | |
| 21 | 00888118128140 | 28-294-14-07 | FZS | CURETTE, SURGICAL, GENERAL USE | 1 | EXTRACTOR | ||
| 22 | 00888118124203 | 25-306-07-71 | PLATE, MIDFACE, L SHP, W/TAB, UNI, 1.5 MM SCREW, CP TITANIUM | JEY | PLATE, BONE | 2 | LEVEL ONE CMF, STERILE | |
| 23 | 00888118122278 | 38-684-21-04 | GAD | RETRACTOR | 1 | HOLDER | ||
| 24 | 00888118121196 | 48-335-04-14 | GAD | RETRACTOR | 1 | RETRACTOR | ||
| 25 | 00888118120205 | 25-300-04-81 | HWT | TEMPLATE | 1 | LEVEL ONE CMF, STERILE | ||
| 26 | 00888118120144 | 24-856-10-07 | HXE | FORK | 1 | FORK | ||
| 27 | 00888118118448 | 995-4496-02 | HWT | TEMPLATE | 1 | LEVEL ONE CMF | ||
| 28 | 00888118118134 | 995-3132-15 | GZX | INSTRUMENT, MICROSURGICAL | 1 | CURETTE | ||
| 29 | 00888118117953 | 51-671-27-09 | HWT | TEMPLATE | 1 | LEVEL ONE CMF | ||
| 30 | 00888118117533 | 39-782-12-04 | KAI | MIRROR, ENT | 1 | MIRROR | ||
| 31 | 00888118114310 | 51-405-42-71 | DIST, CRANIAL, MICRO ZURICH 2, END DRV, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V | PBJ | Cranial Distraction System | 2 | DISTRACTION, INTERNAL, STERILE | |
| 32 | 00888118114150 | 00-102-96-07 | FZS | CURETTE, SURGICAL, GENERAL USE | 1 | CURETTE | ||
| 33 | 00888118113733 | 25-661-07-61 | SCREW, CENTREDRIVE, EMERGENCY, TI-6AL-4V | JEY | PLATE, BONE | 2 | LEVEL ONE CMF | |
| 34 | 00888118112781 | 25-886-19-61 | SCREW, MAXDRIVE, TI-6AL-4V | MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR | 2 | LEVEL ONE CMF | |
| 35 | 00888118112750 | 25-886-13-61 | SCREW, MAXDRIVE, TI-6AL-4V | MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR | 2 | LEVEL ONE CMF | |
| 36 | 00888118112309 | 25-875-08-61 | SCREW, MAXDRIVE, TI-6AL-4V | JEY | PLATE, BONE | 2 | LEVEL ONE CMF | |
| 37 | 00888118110206 | 26-022-16-61 | SCREW, SMARTDRIVE, LOCKING, TI-6AL-4V | HRS | Plate, fixation, bone | 2 | LEVEL ONE SMALL BONE | |
| 38 | 00888118108432 | 60-000-10-09 | HWT | TEMPLATE | 1 | IPS | ||
| 39 | 00888118107879 | 25-878-19-91 | SCREW, MAXDRIVE, BONE GRAFT, DRILL FREE, TI-6AL-4V | HRS | Plate, fixation, bone | 2 | LEVEL ONE CMF | |
| 40 | 00888118106018 | 993-03-8943 | IPS, PEEK, PEEK | GXP,GXN | METHYL METHACRYLATE FOR CRANIOPLASTY,PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE | 2 | IPS | |
| 41 | 00888118105172 | 51-523-12-71 | DIST, ALVEOLAR, MICRO TRACK, END DRV, 1.0-1.2 MM SCREW, TI-6AL-4V | MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR | 2 | DISTRACTION, INTERNAL, STERILE | |
| 42 | 00888118103789 | 52-906-08-71 | HWT | TEMPLATE | 1 | RESORB X, STERILE | ||
| 43 | 00888118104502 | 51-401-93-71 | TROCAR TIP, FOR ACT ARM | LXH | Orthopedic manual surgical instrument | 1 | DISTRACTION, INTERNAL, STERILE | |
| 44 | 00888118103031 | 25-399-37-89 | HWT | TEMPLATE | 1 | LEVEL ONE CMF | ||
| 45 | 00888118099679 | 51-524-25-09 | MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR | 2 | DISTRACTION, INTERNAL | ||
| 46 | 00888118098962 | 14-350-25-07 | GEN | FORCEPS, GENERAL & PLASTIC SURGERY | 1 | FORCEPS | ||
| 47 | 00888118098245 | 43-506-03-07 | EKR | PLUGGER, ROOT CANAL, ENDODONTIC | 1 | PLUGGER | ||
| 48 | 00888118094353 | 995-7090-02 | MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR | 2 | LEVEL ONE CMF | ||
| 49 | 00888118094254 | 00-889-25-87 | GXN,GXP | PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE,METHYL METHACRYLATE FOR CRANIOPLASTY | 2 | IPS | ||
| 50 | 00888118093776 | 995-4743-01 | PLATE, RECON, TLTS, ANGEL TO ANGEL, 2.0-2.5 MM SCREW, CP TITANIUM | MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR | 2 | LEVEL ONE CMF |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 09421904268319 | 4.0 | Volpara Density Map 4.0 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 2 | 09421904268289 | 3.4.2 | Volpara Density Map 3.4.2 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 3 | 09421904268258 | 3.4.2 | VolparaDensity 3.4.2 | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 4 | 09421904268241 | 4.0 | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | ||
| 5 | 09421904268166 | 3.4.1 | VolparaDensity 3.4.1 (Volpara Imaging Software 1.5.5.1) | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 6 | 09421904268128 | 3.3 | Volpara Density Map 3.3 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 7 | 09421904268098 | 3.3 | VolparaDensity 3.3 (Volpara Imaging Software 1.5.3 and 1.5.4) | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 8 | 09421904268050 | 3.2 | Volpara Density Map 3.2 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 9 | 09421904268029 | 3.2 | VolparaDensity 3.2 (Volpara Imaging Software 1.5.2) | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 10 | 09358140000024 | 1.2 | SCI0001 | Quicktome | OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T) | |
| 11 | 09358140000017 | 1.1 | SCI0001 | Quicktome | OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T) | |
| 12 | 09351327000848 | 1.2 | 1200-0000 | OPSInsight™ is intended for use as preoperative surgical planning software to ai OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty. | OPSInsight™ | OPTIMIZED ORTHO PTY LTD |
| 13 | 09351327000091 | 1250-1300 | OPS Plan V.2.0 | Optimized Positioning System (OPS) Plan | OPTIMIZED ORTHO PTY LTD | |
| 14 | 09351327000084 | 1250-1100,1250-1200 | Patient Specific Femoral Guide+Trial Femoral Head | Optimized Positioning System (OPS) Femoral | OPTIMIZED ORTHO PTY LTD | |
| 15 | 09351327000077 | 1250-1300 | OPS Plan | Optimized Positioning System (OPS) Plan | OPTIMIZED ORTHO PTY LTD | |
| 16 | 09351327000060 | 1248-1500, 1248-1700, 1250-1100,1250-1200 | Patient Specific Acetabular Guide ,Trial Acetabulum,Patient Specific Femoral Gui Patient Specific Acetabular Guide ,Trial Acetabulum,Patient Specific Femoral Guide and Trial Femoral Head | Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral | OPTIMIZED ORTHO PTY LTD | |
| 17 | 09351327000053 | 1248-1500, 1248-1700, 1250-1100 | Patient Specific Acetabular Guide, Trial Acetabulum and Patient Specific Femoral Guide | Optimized Positioning System (OPS) and Optimized Postioning System (OPS) Femoral | OPTIMIZED ORTHO PTY LTD | |
| 18 | 09351327000046 | 1250-1200 | Trial Femoral Head | Optimized Ortho Positioning (OPS) Femoral | OPTIMIZED ORTHO PTY LTD | |
| 19 | 09351327000039 | 1250-1100 | Patient Specific Femoral Guide | Optimized Ortho Positioning (OPS) Femoral | OPTIMIZED ORTHO PTY LTD | |
| 20 | 09120105730464 | V2.11 | The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric meas The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices. | KOALA | IB LAB GMBH | |
| 21 | 09120105730037 | V2.05 | The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric meas The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices. | KOALA | IB LAB GMBH | |
| 22 | 08908008302008 | RADSpa RIS-PACS 4.0 | RADSpa RIS-PACS | RADSpa® | TELERAD TECH PRIVATE LIMITED | |
| 23 | 08809466041112 | 1.2.1.466 | QuantorView is an image viewing software dedicated DICOM images produced by imag QuantorView is an image viewing software dedicated DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). QuantorView is a high quality viewing software responsible for displaying PACS image data. It enables physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for researching, teaching, teleconferencing and online collaboration. | QuantorView | DIGIRAY CORP. | |
| 24 | 08809413810471 | ExamVue PACS | The ExamVue PACS is a software solution for the storage, sharing, display and vi The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database. | Box for ExamVue PACS(outside 265mmx185mmx150mm) | JPI HEALTHCARE. CO., LTD. | |
| 25 | 08809413810174 | ExamVue PACS | The ExamVue PACS is a software solution for the storage, sharing, display and vi The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database. | ExamVue | JPI HEALTHCARE. CO., LTD. | |
| 26 | 08809282819957 | 111-083-L | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
| 27 | 08809282819940 | 111-083-R | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
| 28 | 08809282819933 | 111-082-L | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
| 29 | 08809282819926 | 111-082-R | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
| 30 | 08809278790307 | Xelis Dental 2.0 | Xelis Dental 2.0 | INFINITT HEALTHCARE CO.,LTD. | ||
| 31 | 08809278790192 | INFINITT RT PACS | INFINITT RT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 32 | 08809278790130 | INFINITT PACS 7.0 | INFINITT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 33 | 08809278790123 | INFINITT ULite | INFINITT ULite | INFINITT HEALTHCARE CO.,LTD. | ||
| 34 | 08809278790116 | Xelis Dental | Xelis Dental | INFINITT HEALTHCARE CO.,LTD. | ||
| 35 | 08809278790109 | Xelis Cardiac | Xelis Cardiac | INFINITT HEALTHCARE CO.,LTD. | ||
| 36 | 08809278790093 | Xelis Fusion | Xelis Fusion | INFINITT HEALTHCARE CO.,LTD. | ||
| 37 | 08809278790086 | Xelis 3D | Xelis 3D | INFINITT HEALTHCARE CO.,LTD. | ||
| 38 | 08809278790079 | Xelis | Xelis | INFINITT HEALTHCARE CO.,LTD. | ||
| 39 | 08809278790062 | INFINITT Cardiology PACS | INFINITT Cardiology PACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 40 | 08809278790055 | INFINITT PACS | INFINITT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 41 | 08809278790000 | STARPACS | STARPACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 42 | 08806390885751 | SO-111-228-R | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
| 43 | 08806390885744 | SO-111-228-L | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
| 44 | 08806390885737 | SO-111-227-R | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
| 45 | 08806390885720 | SO-111-227-L | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
| 46 | 08806390876285 | 111-230-R | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
| 47 | 08806390876278 | 111-230-L | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
| 48 | 08806390876261 | 111-229-R | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
| 49 | 08806390876254 | 111-229-L | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
| 50 | 08806390876247 | 111-228-R | Surgical Instrument | JEIL MEDICAL CORPORATION |