| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04571130283152 | NW500 | HKI | Camera, ophthalmic, ac-powered | 2 | NON-MYDRIATIC RETINAL CAMERA NW500 | ||
| 2 | 04571130282612 | MEASURING HEAD CONNECTION CABLE(14m) for COMPU VISION CV-5000 | HKN | Refractor, Manual, Non-Powered, Including Phoropter | 1 | MEASURING HEAD CONNECTION CABLE(14m) for COMPU VISION CV-5000 | ||
| 3 | 04562123288247 | SL-D8Z | HJO | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED | 2 | SLIT LAMP SL-D8Z | ||
| 4 | 04562123289046 | DRI OCT Triton(plus) | HKI,OBO | Camera, ophthalmic, ac-powered,Tomography, optical coherence | 2 | 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plus) | ||
| 5 | 04562123288308 | IMAGEnet 5 | NFJ | System, image management, ophthalmic | 2 | IMAGEnet 5 OPHTHALMIC DATA SYSTEM | ||
| 6 | 04562123288230 | SL-D8Z | HJO | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED | 2 | SLIT LAMP SL-D8Z | ||
| 7 | 04562123285239 | SO-FT02 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | EXTERNAL FIXATION TARGET SO-FT02 for SLIT LAMP SL-2G | ||
| 8 | 04562123283327 | OBSERVATION TUBE | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | OBSERVATION TUBE | ||
| 9 | 04562123280265 | FIXATION TARGET | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | FIXATION TARGET | ||
| 10 | 04571130283015 | POWER SUPPLY UNIT for CV-5000 | HKN | Refractor, Manual, Non-Powered, Including Phoropter | 1 | POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE) | ||
| 11 | 04562123288292 | TRC-NW8F(plus) | HKI | Camera, ophthalmic, ac-powered | 2 | NON-MYDRIATIC RETINAL CAMERA TRC-NW8F(plus) | ||
| 12 | 04562123288254 | TRC-NW8 | HKI | Camera, ophthalmic, ac-powered | 2 | NON-MYDRIATIC RETINAL CAMERA TRC-NW8 | ||
| 13 | 04562123286441 | TL-5A | HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 1 | TL-5A | ||
| 14 | 04562123283495 | SO-AS3 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | AUXILIARY SPRING SO-AS3 | ||
| 15 | 04562123283334 | BEAM SPLITTER | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | BEAM SPLITTER | ||
| 16 | 04562123280531 | PRISM COMPENSATOR for LENSMETER LM-8 | HLM | Instrument, Measuring, Lens, Ac-Powered | 1 | PRISM COMPENSATOR for LENSMETER LM-8 | ||
| 17 | 04560126264640 | INFRARED COMMUNICATION UNIT | HKN | Refractor, Manual, Non-Powered, Including Phoropter | 1 | INFRARED COMMUNICATION UNIT | ||
| 18 | 04562123289817 | BG-5 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | BACKGROUND ILLUMINATION BG-5 | ||
| 19 | 04562123289749 | BG-2GN | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | BACKGROUND ILLUMINATION BG-2GN | ||
| 20 | 04562123289596 | SL-D701 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D701 | ||
| 21 | 04562123289565 | SL-D4 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D4 | ||
| 22 | 04562123289558 | SL-D4 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D4 | ||
| 23 | 04562123288698 | POWER SUPPLY UNIT for CV-5000 | HKN | Refractor, Manual, Non-Powered, Including Phoropter | 1 | POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE) | ||
| 24 | 04562123288582 | IMAGEnet 6 | HKI,OBO,NFJ | Camera, Ophthalmic, Ac-Powered,Tomography, Optical Coherence,System, image manag Camera, Ophthalmic, Ac-Powered,Tomography, Optical Coherence,System, image management, ophthalmic | 2 | IMAGEnet 6 OPHTHALMIC DATA SYSTEM | ||
| 25 | 04562123288285 | SL-D701 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D701 | ||
| 26 | 04562123288223 | SL-D7 | HJO | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED | 2 | SLIT LAMP SL-D7 | ||
| 27 | 04562123288216 | SL-D7 | HJO | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED | 2 | SLIT LAMP SL-D7 | ||
| 28 | 04562123284959 | SL-D4 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D4 | ||
| 29 | 04562123282856 | SL-D4 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D4 | ||
| 30 | 04560126266071 | KR-1W Viewer | HKO | Refractometer, Ophthalmic | 1 | KR-1W Viewer | ||
| 31 | 04571130283084 | PC-50S | HOX | Chart, Visual Acuity | 1 | PIXELCHART PC-50S for COMPU VISION CV-5000 | ||
| 32 | 04562123289848 | TL-211 | HKI | Camera, ophthalmic, ac-powered | 2 | TV RELAY LENS ADAPTER TL-211 for RETINAL CAMERA TRC-50DX | ||
| 33 | 04562123289718 | SO-DFL01 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | DIFFUSION LENS SO-DFL01 for SLIT LAMP SL-D301 | ||
| 34 | 04562123286502 | MS-BS03-50/50 | HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 1 | BEAM SPLITTER MS-BS03-50/50 | ||
| 35 | 04562123283488 | SO-AS2 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | AUXILIARY SPRING SO-AS2 | ||
| 36 | 04562123283310 | OBSERVATION TUBE + BEAM SPLITTER | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | OBSERVATION TUBE + BEAM SPLITTER | ||
| 37 | 04562123289831 | PB-2 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | PARALLEL BINOCULAR TUBE PB-2 | ||
| 38 | 04571130283060 | MC-5S | HOX | Chart, Visual Acuity | 1 | MIRROR CHART MC-5S for COMPU VISION CV-5000 | ||
| 39 | 04571130283039 | KR-800S | HKO | Refractometer, Ophthalmic | 1 | AUTO KERATO-REFRACTOMETER KR-800S | ||
| 40 | 04571130282520 | Chronos | HKO | Refractometer, Ophthalmic | 1 | REFRACTION SYSTEM Chronos | ||
| 41 | 04562123289732 | DIFFUSER | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | DIFFUSER for SLIT LAMP SL-D2, SLIT LAMP SL-D4, SLIT LAMP SL-D4(Type:LED) | ||
| 42 | 04562123289572 | SL-D301 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D301 | ||
| 43 | 04562123289206 | ACP-8 | HOS | Projector, Ophthalmic | 1 | AUTO CHART PROJECTOR ACP-8 | ||
| 44 | 04562123288605 | 3D OCT-1 | OBO,HKI | Tomography, optical coherence,Camera, ophthalmic, ac-powered | 2 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 | ||
| 45 | 04562123288322 | 3D OCT-1 | HKI,OBO | Camera, ophthalmic, ac-powered,Tomography, optical coherence | 2 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 | ||
| 46 | 04562123288315 | SP-1P | NQE | Microscope, specular | 2 | SPECULAR MICROSCOPE SP-1P | ||
| 47 | 04562123288131 | SL-D301 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D301 | ||
| 48 | 04562123283624 | INTERNAL FIXATION TARGET MOUNT | HKI | Camera, ophthalmic, ac-powered | 2 | INTERNAL FIXATION TARGET MOUNT for RETINAL CAMERA TRC-50DX | ||
| 49 | 04562123283471 | SO-AS1 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | AUXILIARY SPRING SO-AS1 | ||
| 50 | 04562123289763 | SO-LED01 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | LED UNIT SO-LED01 for SLIT LAMP SL-D701 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 04059237000877 | 88036 | ANTERION | HEIDELBERG ENGINEERING GMBH | ||
| 2 | 04059237000839 | Software with HEYEX 2 V7.0-US | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 3 | 04059237000815 | Software V7.0-US | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 4 | 04059237000754 | Software with HEYEX 2 V1.2.3 | ANTERION | HEIDELBERG ENGINEERING GMBH | ||
| 5 | 04059237000716 | SP-PWS-2001A [>20000] | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 6 | 04059237000617 | 88036 | ANTERION | HEIDELBERG ENGINEERING GMBH | ||
| 7 | 04059237000594 | Software with HEYEX 2 V6.12_US | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 8 | 04059237000570 | Software 6.12_US | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 9 | 04059237000549 | Software with HEYEX 2 V6.10-US | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 10 | 04059237000525 | Software V6.10-US | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 11 | 04059237000501 | SP-PWS-1001A | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 12 | 04059237000488 | Software with HEYEX 2 V6.14_US | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 13 | 04059237000464 | Software 6.13_US | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 14 | 04059237000396 | Image Capture Module SW V1.2.4 | SPECTRALIS, HEP | HEIDELBERG ENGINEERING GMBH | ||
| 15 | 04059237000358 | Product Famliy with HEYEX 2 SW V6.9b-US | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 16 | 04059237000341 | Product Family SW V6.9.1-US | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 17 | 04059237000310 | Product Family SW V6.8a-US | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 18 | 04059237000303 | Product Family SW V6.8-US | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 19 | 04059237000297 | SPEC-CAM-S2610 | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 20 | 04059237000280 | SPEC-CAM-S2600 | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 21 | 04059237000259 | Image Capture Module SW V1.2 | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 22 | 04059237000242 | HEYEX 2 SW V2.2 | SPECTRALIS, HRT3, HEP | HEIDELBERG ENGINEERING GMBH | ||
| 23 | 04059237000211 | HMO | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 24 | 04059237000150 | UWF1 | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 25 | 04059237000136 | WFO2 | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 26 | 04059237000112 | VAO | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 27 | 04059237000105 | Product Family SW V6.6 | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 28 | 04059237000099 | SPEC-CAM-S3610 | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 29 | 04059237000082 | SPEC-CAM-S1610 | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 30 | 04059237000075 | SPEC-TSP | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 31 | 04059237000068 | SP-PWS-2001A | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 32 | 04059237000051 | SP-PWS-2000A | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 33 | 04059237000044 | SP-PWS-1000A | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 34 | 04059237000037 | SPEC-CAM-S3600 | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 35 | 04059237000020 | SPEC-CAM-S2000 | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 36 | 04059237000013 | SPEC-CAM-S1600 | SPECTRALIS | HEIDELBERG ENGINEERING GMBH | ||
| 37 | 04057748087141 | 6000 | The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscop The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imagining of anterior and posterior ocular structures. | CIRRUS HD-OCT | CARL ZEISS MEDITEC, INC. | |
| 38 | 04057748087127 | CIRRUS Review Software | The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicrosco The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior and posterior ocular structures. The device is indicated for visualizing and measuring anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS normative databases are quantitative tools indicated for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiformlayer thickness, and optic nerve head measurements to a database of normal subjects. The CIRRUS OCT Angiography is indicated as an aid in the visualization of vascular structures ofthe retina and choroid. The CIRRUS HD-OCT is indicated as a diagnostic device to aid in thedetection and management of ocular diseases including, but not limited to, macular holes,cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma. | CIRRUS HD-OCT | CARL ZEISS MEDITEC, INC. | |
| 39 | 04057748087110 | 9000 | The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographicand biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging ofposterior ocular structures. | PLEX Elite | CARL ZEISS MEDITEC, INC. | |
| 40 | 04057748087097 | 500 | The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicrosco The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior and posterior ocular structures. | CIRRUS HD-OCT | CARL ZEISS MEDITEC, INC. | |
| 41 | 04057748087080 | 5000 | The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscop The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imagining of anterior and posterior ocular structures. | CIRRUS HD-OCT | CARL ZEISS MEDITEC, INC. | |
| 42 | 04049539072108 | 7210 | RESCAN 700 | CARL ZEISS MEDITEC AG | ||
| 43 | 04049471096026 | CIRRUS photo 800 | The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopi The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions.These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented.The CIRRUS photo is indicated for in-vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula and optic disc.It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The CIRRUS photo is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma. | CIRRUS photo | CARL ZEISS MEDITEC AG | |
| 44 | 04049471096019 | CIRRUS photo 600 | The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopi The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions.These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented.The CIRRUS photo is indicated for in-vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula and optic disc.It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The CIRRUS photo is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma. | CIRRUS photo | CARL ZEISS MEDITEC AG | |
| 45 | 04049471093162 | VISUCAM 524 | The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye beeing examined under mydriatic and non-mydriatic conditions. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographiacally documented. | VISUCAM 524 | CARL ZEISS MEDITEC AG | |
| 46 | 04049471093155 | VISUCAM 224 | The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye beeing examined under mydriatic and non-mydriatic conditions. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographiacally documented. | VISUCAM 224 | CARL ZEISS MEDITEC AG | |
| 47 | 04049471093032 | FF450plus | The FF 450plus is a monocular retina camera for routine use. It is designed to c The FF 450plus is a monocular retina camera for routine use. It is designed to capture images of the eye, especially the retina area, as well as surrounding areas, to aid diagnosing or monitoring diseases of the eye that may be observed and photographed. If used in combination with dedicated optional equipment (electronic image sensors, digital archiving system) the system allows images to be displayed, stored, manipulated and archived digitally. | FF450plus | CARL ZEISS MEDITEC AG | |
| 48 | 04049471070118 | 1.0 | This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118 This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118(10)200 -> Version 2.0; (01)04049471070118(10)201-> Version 2.0.1; (01)04049471070118(10)251-> Version 2.5.1; (01)04049471070118(10)260-> Version 2.6 | Retina Workplace | CARL ZEISS MEDITEC AG | |
| 49 | 04049471070118 | 1.0 | This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118 This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118(10)200 -> Version 2.0; (01)04049471070118(10)201-> Version 2.0.1; (01)04049471070118(10)251-> Version 2.5.1; (01)04049471070118(10)260-> Version 2.6 | Retina Workplace | CARL ZEISS MEDITEC AG | |
| 50 | 03615020000496 | ANAEYES OCT | ANAEYES OCT for system linkage | ESSILOR INTERNATIONAL |