| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00811608019390 | VESMV | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | Singh MidVitreous (VESMV) | ||
| 2 | 00811608019697 | 12161 | FSO | Microscope, Surgical, General & Plastic Surgery | 1 | Merlin Mount, MW HS HiR | ||
| 3 | 00811608019178 | VEIRID | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | Iridectomy (VEIRID) | ||
| 4 | 00811608018904 | VINVIEW-TCH | PJZ | Camera, Ophthalmic, General-Use | 2 | iNview for iPod Touch (VINVIEW-TCH) | ||
| 5 | 00811608018881 | VINVIEW-5S | PJZ | Camera, Ophthalmic, General-Use | 2 | iNview for iPhone 5s (VINVIEW-5S) | ||
| 6 | 00811608018676 | C20 | HJL | Lens, Condensing, Diagnostic | 1 | 20D Cielo | ||
| 7 | 00811608018621 | VP2ANTK | HKI | Camera, Ophthalmic, Ac-Powered | 2 | Volk Pictor Plus VP2HAND and VP2ANT | ||
| 8 | 00811608018522 | 11732 | FSO | Microscope, Surgical, General & Plastic Surgery | 1 | Merlin Mount, Alcon | ||
| 9 | 00811608018065 | VP1COMPK | Volk Pictor VP1Handset, VP1RET, VP1ANT, VP1OTO, & VP1DERM | |||||
| 10 | 00811608017532 | 11411 | FSO | Microscope, Surgical, General & Plastic Surgery | 1 | Merlin RA Mount, Leica 690 | ||
| 11 | 00811608017433 | 11313 | FSO | Microscope, Surgical, General & Plastic Surgery | 1 | ROLS Infinity, Zeiss - Manual | ||
| 12 | 00811608017334 | 11174 | FSO | Microscope, Surgical, General & Plastic Surgery | 1 | Merlin LPU for CLA, 200 mm | ||
| 13 | 00811608017327 | 11173 | FSO | Microscope, Surgical, General & Plastic Surgery | 1 | Merlin LPU for CLA, 175 mm | ||
| 14 | 00811608017167 | VROLS-LX | FSO | Microscope, Surgical, General & Plastic Surgery | 1 | ROLS Reinverter - Leica, Open Flange | ||
| 15 | 00811608013572 | VG3NF | HKS | Prism, Gonioscopic | 1 | G-3 Goniofundus NF | ||
| 16 | 00811608013541 | VG2NF | HKS | Prism, Gonioscopic | 1 | G-2 Trabeculum NF | ||
| 17 | 00811608013503 | VU3MIRANF+ | HKS | Prism, Gonioscopic | 1 | Uncoated 3 Mirror ANF+ | ||
| 18 | 00811608013329 | VHRD20PACS | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | HR Direct Prism Vit (VHRD20PACS) | ||
| 19 | 00811608013206 | V30PRISMSSVACS | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | 30 Prism SSV ACS (V30PRISMSSVACS) | ||
| 20 | 00811608013183 | VFLATSSVACS | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | Flat SSV ACS (VFLATSSVACS) | ||
| 21 | 00811608013015 | VMQVITSSVACS | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | MiniQuad SSV ACS (VMQVITSSVACS) | ||
| 22 | 00811608012995 | VMQXLVITSSV | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | Mini Quad XL VIT SSV (VMQXLVITSSV) | ||
| 23 | 00811608012957 | VMQVITACS | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | MiniQuad ACS (VMQVITACS) | ||
| 24 | 00811608012810 | VBSL | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | Blumenthal SutureLysis (VBSL) | ||
| 25 | 00811608012797 | VFUNDUS | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | Fundus (VFUNDUS) | ||
| 26 | 00811608012575 | VACNF | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | Area Centralis NF (VACNF) | ||
| 27 | 00811608012490 | VQFL | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | QuadrAspheric (VQFL) | ||
| 28 | 00811608012469 | VAC | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | Area Centralis (VAC) | ||
| 29 | 00811608012162 | VDGTLWF-GD | HJL | Lens, Condensing, Diagnostic | 1 | Digital Wide Field®, Gold | ||
| 30 | 00811608012148 | VDGTLWF-PE | HJL | Lens, Condensing, Diagnostic | 1 | Digital Wide Field®, Purple | ||
| 31 | 00811608012117 | VDGTLWF-BK | HJL | Lens, Condensing, Diagnostic | 1 | Digital Wide Field®, Black | ||
| 32 | 00811608011240 | VDGTLWF-CC | HJL | Lens, Condensing, Diagnostic | 1 | Digital Wide Field®, Custom Color | ||
| 33 | 00811608010861 | V90C-BE | HJL | Lens, Condensing, Diagnostic | 1 | 90D Clear, Blue Ring | ||
| 34 | 00811608010830 | V78C-SR | HJL | Lens, Condensing, Diagnostic | 1 | 78D Clear, Silver Ring | ||
| 35 | 00811608010816 | V78C-GN | HJL | Lens, Condensing, Diagnostic | 1 | 78D Clear, Green Ring | ||
| 36 | 00811608010809 | V78C-PE | HJL | Lens, Condensing, Diagnostic | 1 | 78D Clear, Purple Ring | ||
| 37 | 00811608010281 | VPRC-GD | HJL | Lens, Condensing, Diagnostic | 1 | Pan Retinal 2.2 Clear, Gold Ring | ||
| 38 | 00811608010205 | V30SC | HJL | Lens, Condensing, Diagnostic | 1 | 30D Small Clear | ||
| 39 | 00811608010182 | V28LC-SR | HJL | Lens, Condensing, Diagnostic | 1 | 28D Large Clear, Silver Ring | ||
| 40 | 00811608019383 | VEHRWF | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | HR Wide Field (VEHRWF) | ||
| 41 | 00811608019574 | V90C-CC | HJL | Lens, Condensing, Diagnostic | 1 | 90D Clear, Custom Color Ring | ||
| 42 | 00811608019550 | V20LC-CC | HJL | Lens, Condensing, Diagnostic | 1 | 20D Large Clear, Custom Color Ring | ||
| 43 | 00811608019260 | VEHRC | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | HR Centralis (VEHRC) | ||
| 44 | 00811608019123 | V3MIRD | HKS | Prism, Gonioscopic | Single Use 3-Mirror Gonio | |||
| 45 | 00811608018874 | VIRIDD | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | Disposable Iridotomy (VIRIDD) | ||
| 46 | 00811608018829 | VSLV90 | HJL | Lens, Condensing, Diagnostic | 1 | Silver 90D | ||
| 47 | 00811608018577 | VP2ANT | HKI | Camera, Ophthalmic, Ac-Powered | 2 | Volk Pictor Plus VP2ANT | ||
| 48 | 00811608018072 | 11553 | FSO | Microscope, Surgical, General & Plastic Surgery | 1 | Merlin CLA Mount, Zeiss MD | ||
| 49 | 00811608017242 | VWFD | HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 2 | Disposable Direct Image WideField (VWFD) | ||
| 50 | 00811608013732 | VROLS-Z | FSO | Microscope, Surgical, General & Plastic Surgery | 1 | ROLS Reinverter - Zeiss |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 04582275250107 | NSP | NA | KONAN MEDICAL, INC. | ||
| 2 | 04571130283152 | NW500 | NON-MYDRIATIC RETINAL CAMERA NW500 | TOPCON CORPORATION | ||
| 3 | 04571130283022 | TRC-NW400 | NON-MYDRIATIC RETINAL CAMERA TRC-NW400 | TOPCON CORPORATION | ||
| 4 | 04571130282957 | 3D OCT-1 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2) | TOPCON CORPORATION | ||
| 5 | 04571130282643 | TRC-50DX | RETINAL CAMERA TRC-50DX | TOPCON CORPORATION | ||
| 6 | 04571130282636 | TRC-50DX | RETINAL CAMERA TRC-50DX | TOPCON CORPORATION | ||
| 7 | 04571130282193 | ANTERIOR SEGMENT ATTACHMENT KIT AA-1 | ANTERIOR SEGMENT ATTACHMENT KIT AA-1 | TOPCON CORPORATION | ||
| 8 | 04571130282186 | HA-2 | ANTERIOR ATTACHMENT HA-2 | TOPCON CORPORATION | ||
| 9 | 04562123289923 | EF-2 | EXTERNAL FIXATION TARGET EF-2 | TOPCON CORPORATION | ||
| 10 | 04562123289893 | IF-1 | ICG FILTER ATTACHMENT IF-1 for RETINAL CAMERA TRC-50DX | TOPCON CORPORATION | ||
| 11 | 04562123289848 | TL-211 | TV RELAY LENS ADAPTER TL-211 for RETINAL CAMERA TRC-50DX | TOPCON CORPORATION | ||
| 12 | 04562123289251 | 3D OCT-1 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2) | TOPCON CORPORATION | ||
| 13 | 04562123289046 | DRI OCT Triton(plus) | 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plus) | TOPCON CORPORATION | ||
| 14 | 04562123289039 | DRI OCT Triton | 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton | TOPCON CORPORATION | ||
| 15 | 04562123288605 | 3D OCT-1 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 | TOPCON CORPORATION | ||
| 16 | 04562123288582 | IMAGEnet 6 | IMAGEnet 6 OPHTHALMIC DATA SYSTEM | TOPCON CORPORATION | ||
| 17 | 04562123288322 | 3D OCT-1 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 | TOPCON CORPORATION | ||
| 18 | 04562123288292 | TRC-NW8F(plus) | NON-MYDRIATIC RETINAL CAMERA TRC-NW8F(plus) | TOPCON CORPORATION | ||
| 19 | 04562123288278 | TRC-50DX | RETINAL CAMERA TRC-50DX | TOPCON CORPORATION | ||
| 20 | 04562123288254 | TRC-NW8 | NON-MYDRIATIC RETINAL CAMERA TRC-NW8 | TOPCON CORPORATION | ||
| 21 | 04562123288186 | TRC-NW8F | NON-MYDRIATIC RETINAL CAMERA TRC-NW8F | TOPCON CORPORATION | ||
| 22 | 04562123287325 | TRC-NW400 | NON-MYDRIATIC RETINAL CAMERA TRC-NW400 | TOPCON CORPORATION | ||
| 23 | 04562123283624 | INTERNAL FIXATION TARGET MOUNT | INTERNAL FIXATION TARGET MOUNT for RETINAL CAMERA TRC-50DX | TOPCON CORPORATION | ||
| 24 | 04549292182729 | imageSPECTRUM | CANON INC. | CANON INC. | ||
| 25 | 04549292074345 | CX-1 | CANON INC. | CANON INC. | ||
| 26 | 04549292074338 | CR-2 Plus AF | CANON INC. | CANON INC. | ||
| 27 | 04549292074321 | CR-2 AF | CANON INC. | CANON INC. | ||
| 28 | 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 | |
| 29 | 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 | |
| 30 | 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 | |
| 31 | 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 | |
| 32 | 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 | |
| 33 | 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 | |
| 34 | 03615020000496 | ANAEYES OCT | ANAEYES OCT for system linkage | ESSILOR INTERNATIONAL | ||
| 35 | 03615020000489 | OCT2JT | 3D Optical Coherence Tomography OCT500 is a non-contact, high-resolution tomogra 3D Optical Coherence Tomography OCT500 is a non-contact, high-resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging, and measurement of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, ganglion cell complex, macula, optic nerve head. It is also indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging of anterior ocular structures, including the cornea.The instrument 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, agerelated macular degeneration, and glaucoma. | OCT500 | ESSILOR INTERNATIONAL | |
| 36 | 03615020000465 | RET1IN | Retina 800 is an automatic eye-fundus camera intended for taking digital images Retina 800 is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent | ESSILOR RETINA 800 | ESSILOR INTERNATIONAL | |
| 37 | 03615020000267 | RETINA 400 | Retina 400 is an electromedical system that allows for digitally retrieving, acq Retina 400 is an electromedical system that allows for digitally retrieving, acquiring and processing of a retinal image, for use in ophthalmological diagnosis by medical specialists, and other uses inherent to the professional activity of other operators, optometrists and opticians, to the extent permitted by the laws and regulations for the exercise of their profession.An absolute new entry in the field for retinal imaging, the instrument allows for a direct, "live" monitoring on the computer screen, and capturing also in cases where the pupil diameter is extremely narrow. The instrument, with manual acquisition and electronically guided control, guarantees high precision and repeatability of the measurements. | ESSILOR RETINA 400 | ESSILOR INTERNATIONAL | |
| 38 | 00899281002137 | RetCam Portable | The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye. | RetCam Portable | CLARITY MEDICAL SYSTEMS, INC. | |
| 39 | 00899281002120 | RetCam Shuttle | The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye. | RetCam Shuttle | CLARITY MEDICAL SYSTEMS, INC. | |
| 40 | 00899281002113 | RetCam 3 | RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy captu RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye. | RetCam 3 | CLARITY MEDICAL SYSTEMS, INC. | |
| 41 | 00864222000428 | RetCam Portable | The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye. | RetCam Portable | NATUS MEDICAL INC | |
| 42 | 00864222000411 | RetCam Shuttle | The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye. | RetCam Shuttle | NATUS MEDICAL INC | |
| 43 | 00864222000404 | RetCam 3 | RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy captu RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye. | RetCam 3 | NATUS MEDICAL INC | |
| 44 | 00864218000104 | iScreen Vision Screener 3000 | The iScreen Vision Screener 3000 is a vision screening tool intended to capture The iScreen Vision Screener 3000 is a vision screening tool intended to capture and record red reflex images which contain information on ocular status to aid in eye examination. The iScreen Vision Screener 3000 is intended for use solely for a pediatric population by trained professionals. | iScreen Vision | ISCREEN VISION, INC. | |
| 45 | 00859623006919 | DMI-1000 | 400000 | ASSEMBLY PKGD LIPISCAN - US | MEIBOMIAN GLAND EVALUATOR | TEARSCIENCE, INC. |
| 46 | 00859623006612 | LVI-2000 | 100100 | ASSEMBLY PKGD LIPIVIEW-2 - US | LIPIVIEW II OCULAR SURFACE INTERFEROMETE | TEARSCIENCE, INC. |
| 47 | 00859623006513 | LVI-1001 | 100000 | ASSEMBLY PKGD LIPIVIEW 1 - INTL | LIPIVIEW OCULAR SURFACE INTERFEROMETER | TEARSCIENCE, INC. |
| 48 | 00858848006780 | iCam100 | 700-54524-001 | iCam 12 MP | iCam | OPTOVUE, INC. |
| 49 | 00858848006766 | iFusion | 700-54542-001 | iFusion 80 with 12 MP Camera | iFusion | OPTOVUE, INC. |
| 50 | 00858848006650 | iFusion | 700-49003-005 | iVue NR for iFusion USCFG 230V | iFusion | OPTOVUE, INC. |