| 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 | 04260361440204 | TTA2.51 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures andfunction based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to beused for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 2 | 04260361440198 | TTA2.42 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 3 | 04260361440181 | TTA2.50 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 4 | 04260361440174 | TTA2.41 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 5 | 04260361440167 | TTA2.40 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images.Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 6 | 04260361440150 | IA4 | The IMAGE-ARENA software platform is intended to import, export, store, retrieve The IMAGE-ARENA software platform is intended to import, export, store, retrieve and report digital studies. The IMAGE-ARENA software can import certain digital 2D or 3D image file formats of different modalities. IMAGE-ARENA offers a Generic Clinical Application Package interface in order to connect TOMTEC applications as well as commercially available analysis and quantification tools to the IMAGE-ARENA platform. It is intended as a general purpose digital medical image processing tool.IMAGE-ARENA is not intended to be used for reading of mammography images. | IMAGE-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 7 | 04260361440143 | TTA2 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 8 | 04251880700009 | Yxoss CBR | Yxoss | REOSS GMBH | ||
| 9 | 04251332920023 | 1.12 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 10 | 04251332920016 | 1.10 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 11 | 04251332920009 | 1.8.2 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 12 | 04251332910079 | 7.1.17 | Visage 7 | VISAGE IMAGING GMBH | ||
| 13 | 04251332910062 | 7.1.16 | Visage 7 | VISAGE IMAGING GMBH | ||
| 14 | 04251332910055 | 7.1.15 | Visage 7 | VISAGE IMAGING GMBH | ||
| 15 | 04251332910048 | 7.1.14 | Visage 7 | VISAGE IMAGING GMBH | ||
| 16 | 04251332910031 | 7.1.12 | Visage 7 | VISAGE IMAGING GMBH | ||
| 17 | 04251332910024 | 7.1.11 | Visage 7 | VISAGE IMAGING GMBH | ||
| 18 | 04251332910017 | 7.1.10 | Visage 7 | VISAGE IMAGING GMBH | ||
| 19 | 04251332910000 | 7.1.9 | Visage 7 | VISAGE IMAGING GMBH | ||
| 20 | 04250802900800 | 8.3 | DICOM picture archiving system | dicomPACS | OEHM UND REHBEIN GMBH | |
| 21 | 04250802900411 | 5 | SW1000 | Professional acquisition software for the connection and control of a direct rad Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide. | dicomPACS®DX-R | OEHM UND REHBEIN GMBH |
| 22 | 04250802900404 | 4.3 | SW1000 | Professional acquisition software for the connection and control of a direct rad Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide. | dicomPACS®DX-R | OEHM UND REHBEIN GMBH |
| 23 | 04056869955575 | 10400002 | MAMMOVISTA B.smart | SIEMENS HEALTHCARE GMBH | ||
| 24 | 04056869950181 | 11431561 | syngo.NM Organ Processing | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 25 | 04056869950174 | 11431560 | syngo.MI General | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 26 | 04056869950167 | 11431559 | syngo.MI Neurology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 27 | 04056869950150 | 11431558 | syngo.MI Cardiology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 28 | 04056869950143 | 11431557 | syngo.MM Oncology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 29 | 04056869296210 | 11583169 | syngo.MR Applications | SIEMENS HEALTHCARE GMBH | ||
| 30 | 04056869285801 | 11582847 | syngo.via | SIEMENS HEALTHCARE GMBH | ||
| 31 | 04056869281230 | 10400002 | MAMMOVISTA B.smart | SIEMENS HEALTHCARE GMBH | ||
| 32 | 04056869274621 | 11545288 | AI-Rad Companion Brain MR About Box | AI-Rad Companion Brain MR | SIEMENS HEALTHCARE GMBH | |
| 33 | 04056869272320 | 11552102 | syngo Dynamics VA20I Medical Device Identifier | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 34 | 04056869272313 | 11552103 | syngo Dynamics VA20I Packaging Label | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 35 | 04056869270142 | 11461768 | syngo.via View&GO (Version VA20A) | syngo.via View&GO (Version VA20A) | SIEMENS HEALTHCARE GMBH | |
| 36 | 04056869262567 | 11328180 | syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Applicat syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Application Software VD2 | syngo Application Software | SIEMENS HEALTHCARE GMBH | |
| 37 | 04056869259901 | 11551864 | syngo Dynamics VA20H Package Label | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 38 | 04056869259802 | 11461857 | syngo.via VB50A Medical Device Identifier | syngo.via | SIEMENS HEALTHCARE GMBH | |
| 39 | 04056869257945 | 11294429 | AI-Rad Companion Brain MR About Box | AI-Rad Companion Brain MR | SIEMENS HEALTHCARE GMBH | |
| 40 | 04056869257921 | 11294424 | AI-Rad Companion Engine product label | AI-Rad Companion Engine | SIEMENS HEALTHCARE GMBH | |
| 41 | 04056869256399 | 11551643 | syngo Dynamics VA20H | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 42 | 04056869253244 | 10745960 | syngo Dynamics VA40 Software | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 43 | 04056869251202 | 11270035 | AI-Rad Companion (Engine) | SIEMENS HEALTHCARE GMBH | ||
| 44 | 04056869248653 | 11327988 | syngo.Interventional VB40; Medical Device syngo.Interventional VB40 is covered b syngo.Interventional VB40; Medical Device syngo.Interventional VB40 is covered by NFJ to K190780 syngo Application Software VE20 | syngo.Interventional | SIEMENS HEALTHCARE GMBH | |
| 45 | 04056869247953 | 11368091 | syngo.via VB40A USB Media Virtual Container (Package) | syngo.via | SIEMENS HEALTHCARE GMBH | |
| 46 | 04056869247175 | 10745653 | syngo Dynamics VA20G Packaging Label | SIEMENS HEALTHCARE GMBH | ||
| 47 | 04056869247144 | 10745650 | syngo Dynamics VA20G | SIEMENS HEALTHCARE GMBH | ||
| 48 | 04056869243405 | 11431532 | Scenium | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 49 | 04056869243399 | 11431531 | syngo.SPECT Processing | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 50 | 04056869243382 | 11431530 | syngo.MI Reading | SIEMENS MEDICAL SOLUTIONS USA, INC. |