No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05415067024084 | 1192 | 1192 | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | Swift-Lock™ | |
2 | 05414734406123 | 3183 | 3183 | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | Octrode™ | |
3 | 05414734202459 | 401780 | 401780 | DRF,DRA | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING,CATHETER, STEERABLE | 2 | Livewire™ | |
4 | 05414734203319 | 406805 | 406805 | DYB | INTRODUCER, CATHETER | 2 | Fast-Cath™ | |
5 | 05414734022491 | 406311 | 406311 | DYB | INTRODUCER, CATHETER | 2 | SJM™ | |
6 | 05414734011730 | 406743 | 406743 | DYB | INTRODUCER, CATHETER | 2 | Fast-Cath™ | |
7 | 05414734010832 | 406667 | 406667 | DYB | INTRODUCER, CATHETER | 2 | Maximum™ | |
8 | 05414734206938 | PL | 410187 | DQY | CATHETER, PERCUTANEOUS | 2 | CPS DIRECT™ | |
9 | 05415067017246 | 3186 | 3186 | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | Octrode™ | |
10 | 05415067011107 | A701124 | A701124 | OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 3 | FlexAbility™ | |
11 | 05415067025722 | X | C12359 | Guidewire | DXO,DRG,DQX | TRANSDUCER, PRESSURE, CATHETER TIP,TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIG TRANSDUCER, PRESSURE, CATHETER TIP,TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY,WIRE, GUIDE, CATHETER | PressureWire™ | |
12 | 05415067019615 | 3688 | 3688 | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | Eon C™ | |
13 | 05415067016560 | 3032 | 3032 | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | SJM™ | |
14 | 05414734506779 | DS06003/40 | DS06003/40 | DRB | STYLET, CATHETER | 2 | SJM™ | |
15 | 05414734506762 | DS06002/85 | DS06002/85 | DRB | STYLET, CATHETER | 2 | SJM™ | |
16 | 05414734505345 | DS2M028 | DS2M028 | Guidewire | DQX | WIRE, GUIDE, CATHETER | 2 | CPS Excel™ |
17 | 05414734503662 | DS06003/52 | DS06003/52 | DRB | STYLET, CATHETER | 2 | SJM™ | |
18 | 05415067018052 | H701805 | H701805 | Printer | DQK | Computer, diagnostic, programmable | 2 | NA |
19 | 05414734206914 | PL | 410185 | DQY | CATHETER, PERCUTANEOUS | 2 | CPS DIRECT™ | |
20 | 05414734406130 | 3186 | 3186 | Lead Kit, 60cm Length | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | Octrode™ |
21 | 05414734406024 | 3086 | 3086 | GZB | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | 2 | Octrode™ | |
22 | 05414734405775 | 3852 | 3852 | Patient Programmer | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
23 | 05414734405133 | 1622 | 1622 | Power Adapter, RP Model 3834 | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
24 | 05414734403382 | 7241 | 7241 | Mobile Charger Pouch | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
25 | 05414734402569 | 3714 | 3714 | AC Line Cord | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
26 | 05414734402552 | 3713 | 3713 | AC Power Adapter | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
27 | 05414734402330 | 3386 | 3386 | Extension, 60cm | GZB | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | 2 | NA |
28 | 05414734402323 | 3383 | 3383 | Extension, 30cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
29 | 05414734402309 | 3346 | 3346 | Extension, Dual 4 Channel 60cm | GZB | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | 2 | NA |
30 | 05414734402293 | 3343 | 3343 | Extension, Dual 4 Channel 30cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
31 | 05414734402279 | 3341 | 3341 | Extension, Dual 4 Channel 10cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
32 | 05414734400206 | 1123 | 1123 | Stylet, Straight, 60cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
33 | 05414734401715 | 3189 | 3189 | Lead Kit, 90cm Length | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | Octrode™ |
34 | 05414734401555 | 3086 | 3086 | Trial Lead Kit, 60cm Length | GZB | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | 2 | Octrode™ |
35 | 05414734401173 | 1701 | 1701 | SCS Accessory Kit Sterile | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
36 | 05414734400664 | 1191 | 1191 | Tunneling Tool, 0.156"¿ Diameter | HAO | INSTRUMENT, SURGICAL, NON-POWERED | 1 | NA |
37 | 05414734400657 | 1190 | 1190 | Tunneling Tool, 0.125" Diameter | HAO | INSTRUMENT, SURGICAL, NON-POWERED | 1 | NA |
38 | 05414734400237 | 1126 | 1126 | Stylet, Curved, 90cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
39 | 05414734400220 | 1125 | 1125 | Stylet, Straight, 90cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | NA | |
40 | 05414734400213 | 1124 | 1124 | Stylet, Bent, 60cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
41 | 05414734400190 | 1122 | 1122 | Stylet, Bent, 30cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
42 | 05414734400183 | 1121 | 1121 | Stylet, Straight, 30cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
43 | 05414734400145 | 1116 | 1116 | Epidural Needle, 14 gauge, 6" (15cm) | LHG,GZB | ELECTRODE, SPINAL EPIDURAL,STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | 2 | NA |
44 | 05414734400121 | 1114 | 1114 | Epidural Needle, 14 gauge, 4" (10cm) | GZB | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | 2 | NA |
45 | 05414734400053 | 1106 | 1106 | Lead Anchor, Long | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
46 | 05414734400022 | 1102 | 1102 | Guide Wire for Percutaneous Leads | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
47 | 05414734219112 | H21911 | H21911 | Touch Screen Computer | JOQ | GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE | 2 | EP-4™ |
48 | 05414734206907 | PL | 410184 | DQY | CATHETER, PERCUTANEOUS | 2 | CPS DIRECT™ | |
49 | 05414734218337 | DS2A004 | DS2A004 | DQY | CATHETER, PERCUTANEOUS | 2 | CPS DIRECT™ | |
50 | 05414734218313 | SLII | DS2C017 | Slittable Outer Guide Catheter | DQY | CATHETER, PERCUTANEOUS | 2 | CPS DIRECT™ |
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 OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/mouse. | 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 The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 2.0 mm to 4.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. | Pantheris SV | AVINGER, INC. |
30 | 00851354004387 | A400X | A400X | The Pantheris System is intended to remove plaque (atherectomy) from partially o The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. | Pantheris | AVINGER, INC. |
31 | 00851354004370 | A400 | A400 | The Pantheris System is intended to remove plaque (atherectomy) from partially o The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. | Pantheris | AVINGER, INC. |
32 | 00851354004301 | U250 | U250 | Lightbox Umbilical is intended for use in peripheral vascular procedures in conj Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product. | Lightbox Umbilical | AVINGER, INC. |
33 | 00851354004189 | O200 | O200 | The Ocelot System is intended to facilitate the intraluminal placement of conven The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature. | 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 The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor. | 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 The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that facilitates tissue imaging. The consumable set consists of a Specimen Tray and Specimen Lid. The Specimen Tray engages with the device to initiate scanning and the Specimen Lid facilitates engaging vacuum to enable vacuum assisted specimen positioning during image acquisition. | Specimen Immobilizer | PERIMETER MEDICAL IMAGING AI, INC. |