| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04582643135135 | WHN10X-H | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | EYEPIECE | ||
| 2 | 04582643135081 | 45-ND6 | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | 6 PERCENT ND FILTER | ||
| 3 | 04582643134930 | IX3-D6RES | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | CODED 6 POSITION NOSEPIECE | ||
| 4 | 04582643135142 | U-CT30-2 | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | CENTERING TELESCOPE | ||
| 5 | 04582643134992 | IX3-CAS | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | CODED INTERMEDIATE MAGNIFICATION CHANGER | ||
| 6 | 04582643134923 | IX73P2F | The intended use can be applied only in US. | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | IX73 2PORT FRAME | |
| 7 | 04582643135050 | U-RMT | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | EXTENSION CORD | ||
| 8 | 04582643135043 | TH4-100 | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | POWER SUPPLY UNIT | ||
| 9 | 04582643135128 | WHN10X | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | EYEPIECE | ||
| 10 | 04582643135111 | U-TBI90 | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | TILTING BINOCULAR TUBE | ||
| 11 | 04582643135104 | IX3-AN | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | ANALYZER SLIDER | ||
| 12 | 04582643135029 | U-LEDPS | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | LED POWER SUPPLY | ||
| 13 | 04582643135012 | IX3-LHLEDC | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | LED LAMP HOUSE | ||
| 14 | 04582643134985 | U-IFCBL200 | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | INTERFACE CABLE, 200 CM | ||
| 15 | 04582643134961 | IX3-CBM | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | CONTROL BOX M | ||
| 16 | 04582643135173 | IX3-MLWCDA | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | MOTORIZED MIDDLE LONG WORKING DISTANCE CONDENSER | ||
| 17 | 04582643135067 | 45FR | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | FROST FILER 45MM | ||
| 18 | 04582643135036 | U-LH100-3 | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | 100W HALOGEN LAMP HOUSING | ||
| 19 | 04582643134978 | U-HSCBM | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | HAND SWITCH | ||
| 20 | 04582643134954 | U-NPCBL100 | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | D6RES CABLE,100 CM | ||
| 21 | 04582643134947 | IX3-D6REA | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | MOTORIZED 6 POSITION NOSEPIECE | ||
| 22 | 04582643135203 | LUCPLFLN40XRC | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | UIS2 OBJECTIVE LENS FOR BIOLOGY | ||
| 23 | 04582643135197 | LUCPLFLN20XRC | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | UIS2 OBJECTIVE LENS FOR BIOLOGY | ||
| 24 | 04582643135180 | CPLFLN10XRC | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | UIS2 OBJECTIVE LENS FOR BIOLOGY | ||
| 25 | 04582643135005 | IX3-ILL | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | TRANSMITTED ILLUMINATOR | ||
| 26 | 04582643134695 | UPLFLN4X | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | UNIVERSAL PLAN SEMI-APOCHROMATIC OBJECTIVE LENS | ||
| 27 | 04582643135098 | 45-ND25 | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | 25 PERCENT ND FILTER | ||
| 28 | 04582643135074 | 45-LBD-IF | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | LBD FILTER | ||
| 29 | 04582643135159 | IX3-SVR | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | MECHANICAL STAGE WITH RIGHT HANDLE | ||
| 30 | 04582643130024 | JC12V100WHAL-L | MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 1 | 12 V, 100 W LONG-LIFE HALOGEN BULB |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 09348265003086 | GERI-SCA-05 | Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. T Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables multiple users to access and review patient/embryo data, using a Chrome browser on their PC workstations. | Geri Software Connect and Assess 2.0 | GENEA BIOMEDX PTY LTD | |
| 2 | 09348265003079 | GERI-SCA-04 | Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. T Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables multiple users to access and review patient/embryo data, using a Chrome browser on their PC workstations. | Geri Software Connect and Assess 1.3 | GENEA BIOMEDX PTY LTD | |
| 3 | 09348265003024 | GERI-GCS-01 | Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. T Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables multiple users to access and review patient/embryo data, using a Chrome browser on their PC workstations. | Geri Connect Server (including software) | GENEA BIOMEDX PTY LTD | |
| 4 | 09348265003000 | GERI-INS-01 | The Geri Embryo Incubator is a benchtop incubator with six modular incubation ch The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics thattake time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter used to filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders.The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings. | Geri Embryo Incubator | GENEA BIOMEDX PTY LTD | |
| 5 | 06909262200477 | Axiolab 5 | 430037-9120-000 | ZEISS Axiolab | CARL ZEISS SUZHOU CO., LTD. | |
| 6 | 06909262200460 | Axiolab 5 | 430037-9110-000 | ZEISS Axiolab | CARL ZEISS SUZHOU CO., LTD. | |
| 7 | 06909262200422 | Axioscope 5 | 430035-9261-000 | ZEISS Axioscope | CARL ZEISS SUZHOU CO., LTD. | |
| 8 | 06909262200378 | Axioscope 5 | 430035-9201-000 | ZEISS Axioscope | CARL ZEISS SUZHOU CO., LTD. | |
| 9 | 06909262200330 | Axioscope 5 | 430035-9061-000 | ZEISS Axioscope | CARL ZEISS SUZHOU CO., LTD. | |
| 10 | 06909262200323 | Axioscope 5 | 430035-9032-000 | ZEISS Axioscope | CARL ZEISS SUZHOU CO., LTD. | |
| 11 | 06909262200316 | Axio Lab.A1 | 430037-9000-000 | ZEISS Axio Lab | CARL ZEISS SUZHOU CO., LTD. | |
| 12 | 06909262200293 | Axiolab 5 | 430037-9070-000 | ZEISS Axiolab | CARL ZEISS SUZHOU CO., LTD. | |
| 13 | 06909262200286 | Axiolab 5 | 430037-9060-000 | ZEISS Axiolab | CARL ZEISS SUZHOU CO., LTD. | |
| 14 | 06909262200248 | Axiolab 5 | 430037-9021-000 | ZEISS Axiolab | CARL ZEISS SUZHOU CO., LTD. | |
| 15 | 06909262200231 | Axiolab 5 | 430037-9011-000 | ZEISS Axiolab | CARL ZEISS SUZHOU CO., LTD. | |
| 16 | 06909262200125 | Axio Lab.A1 | 430037-9020-000 | ZEISS Axio Lab | CARL ZEISS SUZHOU CO., LTD. | |
| 17 | 06909262200118 | Axio Lab.A1 | 430037-9010-000 | ZEISS Axio Lab | CARL ZEISS SUZHOU CO., LTD. | |
| 18 | 06909262200064 | Axio Vert.A1 | 431030-9040-000 | ZEISS Axio Vert | CARL ZEISS SUZHOU CO., LTD. | |
| 19 | 06909262200057 | Axio Vert.A1 | 431030-9010-000 | ZEISS Axio Vert | CARL ZEISS SUZHOU CO., LTD. | |
| 20 | 06909262200040 | Axio Vert.A1 | 431030-9000-000 | ZEISS Axio Vert | CARL ZEISS SUZHOU CO., LTD. | |
| 21 | 05712714604010 | ES-P1 | 16401 | EmbryoScope+ consists of the following devices with the following indications fo EmbryoScope+ consists of the following devices with the following indications for use:The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development.The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by theEmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotatedinformation on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not controlany hardware components in the EmbryoScope+ incubator.The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters.The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images. | EmbryoScope+ | VITROLIFE A/S |
| 22 | 04953170413254 | LUCPLFLN40XRC | UIS2 OBJECTIVE LENS FOR BIOLOGY | OLYMPUS CORPORATION | ||
| 23 | 04953170413247 | LUCPLFLN20XRC | UIS2 OBJECTIVE LENS FOR BIOLOGY | OLYMPUS CORPORATION | ||
| 24 | 04953170413230 | CPLFLN10XRC | UIS2 OBJECTIVE LENS FOR BIOLOGY | OLYMPUS CORPORATION | ||
| 25 | 04953170413223 | IX3-MLWCDA | MOTORIZED MIDDLE LONG WORKING DISTANCE CONDENSER | OLYMPUS CORPORATION | ||
| 26 | 04953170413216 | IX2-MLWCD | MID LONG WORKING DISTANCE CONDENSER | OLYMPUS CORPORATION | ||
| 27 | 04953170413209 | IX3-SVR | MECHANICAL STAGE WITH RIGHT HANDLE | OLYMPUS CORPORATION | ||
| 28 | 04953170413193 | U-CT30-2 | CENTERING TELESCOPE | OLYMPUS CORPORATION | ||
| 29 | 04953170413186 | WHN10X-H | EYEPIECE | OLYMPUS CORPORATION | ||
| 30 | 04953170413179 | WHN10X | EYEPIECE | OLYMPUS CORPORATION | ||
| 31 | 04953170413162 | U-TBI90 | TILTING BINOCULAR TUBE | OLYMPUS CORPORATION | ||
| 32 | 04953170413155 | IX3-AN | ANALYZER SLIDER | OLYMPUS CORPORATION | ||
| 33 | 04953170413148 | 45-ND25 | 25 PERCENT ND FILTER | OLYMPUS CORPORATION | ||
| 34 | 04953170413131 | 45-ND6 | 6 PERCENT ND FILTER | OLYMPUS CORPORATION | ||
| 35 | 04953170413124 | 45-LBD-IF | LBD FILTER | OLYMPUS CORPORATION | ||
| 36 | 04953170413117 | 45FR | FROST FILER 45MM | OLYMPUS CORPORATION | ||
| 37 | 04953170413100 | U-RMT | EXTENSION CORD | OLYMPUS CORPORATION | ||
| 38 | 04953170413094 | TH4-100 | POWER SUPPLY UNIT | OLYMPUS CORPORATION | ||
| 39 | 04953170413087 | U-LH100-3 | 100W HALOGEN LAMP HOUSING | OLYMPUS CORPORATION | ||
| 40 | 04953170413070 | U-LEDPS | LED POWER SUPPLY | OLYMPUS CORPORATION | ||
| 41 | 04953170413063 | IX3-LHLEDC | LED LAMP HOUSE | OLYMPUS CORPORATION | ||
| 42 | 04953170413056 | IX3-ILL | TRANSMITTED ILLUMINATOR | OLYMPUS CORPORATION | ||
| 43 | 04953170413049 | IX3-CAS | CODED INTERMEDIATE MAGNIFICATION CHANGER | OLYMPUS CORPORATION | ||
| 44 | 04953170413032 | U-IFCBL200 | INTERFACE CABLE, 200 CM | OLYMPUS CORPORATION | ||
| 45 | 04953170413025 | U-HSCBM | HAND SWITCH | OLYMPUS CORPORATION | ||
| 46 | 04953170413018 | IX3-CBM | CONTROL BOX M | OLYMPUS CORPORATION | ||
| 47 | 04953170413001 | U-NPCBL100 | D6RES CABLE,100 CM | OLYMPUS CORPORATION | ||
| 48 | 04953170412998 | IX3-D6REA | MOTORIZED 6 POSITION NOSEPIECE | OLYMPUS CORPORATION | ||
| 49 | 04953170412981 | IX3-D6RES | CODED 6 POSITION NOSEPIECE | OLYMPUS CORPORATION | ||
| 50 | 04953170412974 | IX73P2F | The intended use can be applied only in US. | IX73 2PORT FRAME | OLYMPUS CORPORATION |