No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00859591006249 | 94301-MI | 94301-MI | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Console with IRIS | |
2 | 00859591006195 | 95501-14 | 95501-14 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Low Profile Imaging Probe, 14mm Working Distance | |
3 | 00859591006096 | 94101-R | 94101-R | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Console Refurbished | |
4 | 00859591006065 | 95301-M-17 | 95301-M-17 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Probe 17mm | |
5 | 00859591006270 | 94301-MI-UPG-R | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Console with IRIS, Upgraded, Refurbished | ||
6 | 00859591006225 | 94301-M-UPG-R | 94301-M-UPG-R | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Upgrade Refurbished | |
7 | 00859591006218 | 94301-M-UPG | 94301-M-UPG | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging System with Targeted Biopsy - Upgrade | |
8 | 00859591006171 | 95101-14C | 95101-14C | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Probe 14mm Clinical | |
9 | 00859591006164 | 95101-20C | 95101-20C | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Probe 20mm Clinical | |
10 | 00859591006034 | 95101-17 | 95101-17 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Probe 17mm | |
11 | 00859591006263 | 94301-MI-UPG | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Console with IRIS, Upgraded | ||
12 | 00859591006133 | 95301-M-20C | 95301-M-20C | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Probe 20mm Clinical | |
13 | 00859591006058 | 95301-M-14 | 95301-M-14 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Probe 14mm | |
14 | 00859591006256 | 94301-MI-R | 94301-MI-R | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Console with IRIS, Refurbished | |
15 | 00859591006188 | 95501-LP | 95501-LP | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Low Profile Imaging Probe, 0mm Working Distance | |
16 | 00859591006201 | 95501-20 | 95501-20 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Low Profile Imaging Probe, 20mm Working Distance | |
17 | 00859591006126 | 95301-M-17C | 95301-M-17C | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Probe 17mm Clinical | |
18 | 00859591006102 | 94301-M | 94301-M | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Console | |
19 | 00859591006232 | 96101-60 | 96101-60 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | NvisionVLE Inflation Kit | ||
20 | 00859591006157 | 95101-17C | 95101-17C | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Probe 17mm Clinical | |
21 | 00859591006119 | 94301-M-R | 94301-M-R | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Console Refurbished | |
22 | 00859591006072 | 95301-M-20 | 95301-M-20 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Probe 20mm | |
23 | 00859591006140 | 95301-M-14C | 95301-M-14C | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Probe 14mm Clinical | |
24 | 00859591006089 | 94101 | 94101 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Console | |
25 | 00859591006041 | 95101-20 | 95101-20 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Probe 20mm |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00859910007049 | Gentuity Review Station | G80-01 | Gentuity Off-line Review Station includes computer, monitor, keyboard, and mouse. | Gentuity | GENTUITY LLC |
2 | 00859910007032 | Gentuity Imaging System G10-01 K192922 | Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, | Gentuity HF-OCT Imaging System | GENTUITY LLC | |
3 | 00859591006270 | 94301-MI-UPG-R | NvisionVLE Marking Console with IRIS, Upgraded, Refurbished | NINEPOINT MEDICAL, INC. | ||
4 | 00859591006263 | 94301-MI-UPG | NvisionVLE Marking Console with IRIS, Upgraded | NINEPOINT MEDICAL, INC. | ||
5 | 00859591006256 | 94301-MI-R | 94301-MI-R | NvisionVLE Marking Console with IRIS, Refurbished | NINEPOINT MEDICAL, INC. | |
6 | 00859591006249 | 94301-MI | 94301-MI | NvisionVLE Marking Console with IRIS | NINEPOINT MEDICAL, INC. | |
7 | 00859591006232 | 96101-60 | 96101-60 | NvisionVLE Inflation Kit | NINEPOINT MEDICAL, INC. | |
8 | 00859591006225 | 94301-M-UPG-R | 94301-M-UPG-R | NvisionVLE Marking Upgrade Refurbished | NINEPOINT MEDICAL, INC. | |
9 | 00859591006218 | 94301-M-UPG | 94301-M-UPG | NvisionVLE Imaging System with Targeted Biopsy - Upgrade | NINEPOINT MEDICAL, INC. | |
10 | 00859591006201 | 95501-20 | 95501-20 | NvisionVLE Low Profile Imaging Probe, 20mm Working Distance | NINEPOINT MEDICAL, INC. | |
11 | 00859591006195 | 95501-14 | 95501-14 | NvisionVLE Low Profile Imaging Probe, 14mm Working Distance | NINEPOINT MEDICAL, INC. | |
12 | 00859591006188 | 95501-LP | 95501-LP | NvisionVLE Low Profile Imaging Probe, 0mm Working Distance | NINEPOINT MEDICAL, INC. | |
13 | 00859591006171 | 95101-14C | 95101-14C | NvisionVLE Imaging Probe 14mm Clinical | NINEPOINT MEDICAL, INC. | |
14 | 00859591006164 | 95101-20C | 95101-20C | NvisionVLE Imaging Probe 20mm Clinical | NINEPOINT MEDICAL, INC. | |
15 | 00859591006157 | 95101-17C | 95101-17C | NvisionVLE Imaging Probe 17mm Clinical | NINEPOINT MEDICAL, INC. | |
16 | 00859591006140 | 95301-M-14C | 95301-M-14C | NvisionVLE Marking Probe 14mm Clinical | NINEPOINT MEDICAL, INC. | |
17 | 00859591006133 | 95301-M-20C | 95301-M-20C | NvisionVLE Marking Probe 20mm Clinical | NINEPOINT MEDICAL, INC. | |
18 | 00859591006126 | 95301-M-17C | 95301-M-17C | NvisionVLE Marking Probe 17mm Clinical | NINEPOINT MEDICAL, INC. | |
19 | 00859591006119 | 94301-M-R | 94301-M-R | NvisionVLE Marking Console Refurbished | NINEPOINT MEDICAL, INC. | |
20 | 00859591006102 | 94301-M | 94301-M | NvisionVLE Marking Console | NINEPOINT MEDICAL, INC. | |
21 | 00859591006096 | 94101-R | 94101-R | NvisionVLE Imaging Console Refurbished | NINEPOINT MEDICAL, INC. | |
22 | 00859591006089 | 94101 | 94101 | NvisionVLE Imaging Console | NINEPOINT MEDICAL, INC. | |
23 | 00859591006072 | 95301-M-20 | 95301-M-20 | NvisionVLE Marking Probe 20mm | NINEPOINT MEDICAL, INC. | |
24 | 00859591006065 | 95301-M-17 | 95301-M-17 | NvisionVLE Marking Probe 17mm | NINEPOINT MEDICAL, INC. | |
25 | 00859591006058 | 95301-M-14 | 95301-M-14 | NvisionVLE Marking Probe 14mm | NINEPOINT MEDICAL, INC. | |
26 | 00859591006041 | 95101-20 | 95101-20 | NvisionVLE Imaging Probe 20mm | NINEPOINT MEDICAL, INC. | |
27 | 00859591006034 | 95101-17 | 95101-17 | NvisionVLE Imaging Probe 17mm | NINEPOINT MEDICAL, INC. | |
28 | 00859591006027 | 95101-14 | 95101-14 | NvisionVLE Imaging Probe 14mm | NINEPOINT MEDICAL, INC. | |
29 | 00851354004417 | A140-SV | A140-SV | The Pantheris SV System is intended to remove plaque (atherectomy) from partiall | Pantheris SV | AVINGER, INC. |
30 | 00851354004387 | A400X | A400X | The Pantheris System is intended to remove plaque (atherectomy) from partially o | Pantheris | AVINGER, INC. |
31 | 00851354004370 | A400 | A400 | The Pantheris System is intended to remove plaque (atherectomy) from partially o | Pantheris | AVINGER, INC. |
32 | 00851354004301 | U250 | U250 | Lightbox Umbilical is intended for use in peripheral vascular procedures in conj | Lightbox Umbilical | AVINGER, INC. |
33 | 00851354004189 | O200 | O200 | The Ocelot System is intended to facilitate the intraluminal placement of conven | Ocelot III | AVINGER, INC. |
34 | 00812059021994 | Mobile System | C408667 | Installation Kit | OPTIS™ | LIGHTLAB IMAGING, INC. |
35 | 00812059021987 | Mobile System | C408666 | Installation Kit | OPTIS™ | LIGHTLAB IMAGING, INC. |
36 | 00812059021925 | Software Upgrade | E4-STD-WW | Software Upgrade | OPTIS™ | LIGHTLAB IMAGING, INC. |
37 | 00812059021918 | Metallic Stent Optimization Software | E4-FULL-WW | Software Upgrade | OPTIS™ | LIGHTLAB IMAGING, INC. |
38 | 00812059021536 | C.0.4 Software Upgrade | 15211-01 | Software Upgrade Kit | C7-XR™ | LIGHTLAB IMAGING, INC. |
39 | 00812059021482 | D.1 Software | 100074942 | Software Upgrade Kit | ILUMIEN™ | LIGHTLAB IMAGING, INC. |
40 | 00812059021444 | C408663 | C408663 | Tableside Controller | OPTIS™ | LIGHTLAB IMAGING, INC. |
41 | 00812059021437 | Mobile System | C408662 | Upgrade Kit | OPTIS™ | LIGHTLAB IMAGING, INC. |
42 | 00812059021420 | Mobile System | C408661 | Imaging System | OPTIS™ | LIGHTLAB IMAGING, INC. |
43 | 00812059021390 | Integrated System E.2 Software | C408657 | Software Upgrade Kit | OPTIS™ | LIGHTLAB IMAGING, INC. |
44 | 00812059021383 | OPTIS™ E.2 Software | C408656 | Software Upgrade Kit | ILUMIEN™ | LIGHTLAB IMAGING, INC. |
45 | 00812059021338 | D.2 Software | C408660 | Ilumien™ | LIGHTLAB IMAGING, INC. | |
46 | 00812059020560 | D.1.1 Software | 100111860 | Software Upgrade Kit | ILUMIEN™ | LIGHTLAB IMAGING, INC. |
47 | 00812059020126 | C408653 | C408653 | Mobile Workstation | OPTIS™ | LIGHTLAB IMAGING, INC. |
48 | 00812059020003 | Integrated System | C408654 | Installation Kit | OPTIS™ | LIGHTLAB IMAGING, INC. |
49 | 00754016215049 | PMI001OCT21 | ASY-2000 | The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imag | S-Series OCT | PERIMETER MEDICAL IMAGING AI, INC. |
50 | 00754016215025 | PMI010CON21 | ASY-2600 | The OTIS 2.1 system includes a single-use specimen container, the Consumable Set | Specimen Immobilizer | PERIMETER MEDICAL IMAGING AI, INC. |