No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00815686020064 | SYS-2000 | SYS-2000 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4 System V2, 120V, 60Hz | |
2 | 00815686020057 | SYS-1500 | SYS-1500 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiNView System | |
3 | 00815686021108 | INS-5700 | INS-5700 | JAK | System, X-Ray, Tomography, Computed | SPiN EWC – Biopsy Guide Kit | ||
4 | 00815686021078 | SFT-0007 | SFT-0007 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiNDrive Software Application | |
5 | 00815686020736 | INS-5600 | INS-5600 | JAK | System, X-Ray, Tomography, Computed | SPiNPerc Biopsy Needle Guide Kit | ||
6 | 00815686020071 | SYS-2230 | SYS-2230 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4 System V2, 230V, 50Hz | |
7 | 00815686020637 | INS-5410 | INS-5410 | JAK | System, X-Ray, Tomography, Computed | Always-On Tip Tracked 22ga ANSO Flexible Needle, 15mm L, 1.8mm OD | ||
8 | 00815686020590 | INS-0382 | INS-0382 | JAK | System, X-Ray, Tomography, Computed | Always-On Tip Tracked 19ga ANSO Histology Needle, 15mm L, 1.8mm OD | ||
9 | 00815686020538 | INS-0352 | INS-0352 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked Brush, 15mm L, 1.8mm OD | |
10 | 00815686020033 | SYS-0185 | SYS-0185 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiNPlanning Laptop Workstation | |
11 | 00815686020446 | INS-0305 | INS-0305 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked Guidewire, 1.0mm, 950mm | |
12 | 00815686021290 | INS-5915 | INS-5915 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 180 Degrees For Use With Olympus 190 Scopes | |
13 | 00815686021269 | INS-5905 | INS-5905 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 180 Degrees For Use With Olympus Scopes | |
14 | 00815686020354 | INS-5034 | INS-5034 | JAK | System, X-Ray, Tomography, Computed | 17ga LG, 123mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
15 | 00815686020293 | INS-5028 | INS-5028 | JAK | System, X-Ray, Tomography, Computed | 19 UTW, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
16 | 00815686020279 | INS-5026 | INS-5026 | JAK | System, X-Ray, Tomography, Computed | 18ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
17 | 00815686020576 | INS-0372 | INS-0372 | JAK | System, X-Ray, Tomography, Computed | Always-On Tip Tracked Forceps, 1.8mm OD, Serrated Cup | ||
18 | 00815686020477 | INS-0322 | INS-0322 | JAK | System, X-Ray, Tomography, Computed | 2 | View Peripheral Catheter, 3.2mm OD, 2.0mm WC | |
19 | 00815686021153 | INS-5900 | INS-5900 | JAK | System, X-Ray, Tomography, Computed | SPiN Access Catheter - Biopsy Guide Kit | ||
20 | 00815686021313 | INS-5925 | INS-5925 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 180 Degrees For Use With Pentax Scopes | |
21 | 00815686021276 | INS-5910 | INS-5910 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 90 Degrees For Use With Olympus 190 Scopes | |
22 | 00815686021177 | INS-5911 | INS-5911 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 90 Degree Catheter | |
23 | 00815686021146 | INS-5611 | INS-5611 | JAK | System, X-Ray, Tomography, Computed | SPiN Perc Localization Needle 19ga x 105mm, 2cm marking zone | ||
24 | 00815686020361 | INS-5036 | INS-5036 | JAK | System, X-Ray, Tomography, Computed | 22 UTW, 125mm Always-On Tip Tracked Biopsy Needle, Trocar Point | ||
25 | 00815686020323 | INS-5031 | INS-5031 | JAK | System, X-Ray, Tomography, Computed | 19 UTW, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
26 | 00815686020262 | INS-5025 | INS-5025 | JAK | System, X-Ray, Tomography, Computed | 18ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
27 | 00815686020118 | SYS-4230 | SYS-4230 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Thoracic Navigation System, 230V, 50Hz | |
28 | 00815686020088 | SYS-3000 | SYS-3000 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4 System, 120V, 60Hz | |
29 | 00815686020712 | INS-5323 | INS-5323 | JAK | System, X-Ray, Tomography, Computed | Slidding Stopper 1.4 - 1.9 OD | ||
30 | 00815686021122 | INS-5620 | INS-5620 | JAK | System, X-Ray, Tomography, Computed | SPiN Perc Kit | ||
31 | 00815686021061 | SFT-0004 | SFT-0004 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4IR Software Application | |
32 | 00815686020439 | INS-0304 | INS-0304 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Trip Tracked Guidewire, 1.0mm, 735mm | |
33 | 00815686020392 | INS-0048 | INS-0048 | JAK | System, X-Ray, Tomography, Computed | 2 | vPad2 Connector Cable | |
34 | 00815686021252 | INS-5903 | INS-5903 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter Adapter, Pentax | |
35 | 00815686021160 | INS-5901 | INS-5901 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter Locking Device, Olympus | |
36 | 00815686020309 | INS-5029 | INS-5029 | JAK | System, X-Ray, Tomography, Computed | 19 UTW, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
37 | 00815686020255 | INS-5024 | INS-5024 | JAK | System, X-Ray, Tomography, Computed | 17ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
38 | 00815686020231 | INS-5022 | INS-5022 | JAK | System, X-Ray, Tomography, Computed | 17ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
39 | 00815686020651 | INS-5450 | INS-5450 | JAK | System, X-Ray, Tomography, Computed | SPiN Xtend 2.0mm OD, 21ga | ||
40 | 00815686020514 | INS-0342 | INS-0342 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked 20ga Aspiration Needle, 15mm L, 1.8mm OD | |
41 | 00815686021085 | SFT-0010 | SFT-0010 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiNPlanning Software Application | |
42 | 00815686020927 | INS-5035 | INS-5035 | JAK | System, X-Ray, Tomography, Computed | 17ga LG, 73mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
43 | 00815686021245 | INS-5902 | INS-5902 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter Adapter, Olympus 190 | |
44 | 00815686021207 | INS-5300 | INS-5300 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked Triple Needle Brush, 12mm L, 1.8mm OD | |
45 | 00815686020217 | INS-5016 | INS-5016 | JAK | System, X-Ray, Tomography, Computed | 17ga, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
46 | 00815686020705 | INS-5040 | INS-5040 | JAK | System, X-Ray, Tomography, Computed | Always-On TIp Tracked Universal Tracker, LG, 7-12ga | ||
47 | 00815686020644 | INS-5440 | INS-5440 | JAK | System, X-Ray, Tomography, Computed | View Peripheral Catheter, 3.8mm OD, 2.5mm WC | ||
48 | 00815686021139 | INS-5610 | INS-5610 | JAK | System, X-Ray, Tomography, Computed | SPiN Perc Localization Needle 19ga x 105mm, 1cm marking zone | ||
49 | 00815686020286 | INS-5027 | INS-5027 | JAK | System, X-Ray, Tomography, Computed | 18ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
50 | 00815686020248 | INS-5023 | INS-5023 | JAK | System, X-Ray, Tomography, Computed | 17ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 03760305400086 | 30-0001 | 30-0001-01-USA | The EPIONE device is a user controlled, stereotactic accessory intended to assis The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures | EPIONE | QUANTUM SURGICAL |
2 | 03760305400079 | 02-0044 | 02-0044 | The Navigation Probe is an instrument of the EPIONE device. It enables visualizi The Navigation Probe is an instrument of the EPIONE device. It enables visualizingreference points or anatomical landmarks in the medical images. It allows the verificationof patient registration accuracy, using external anatomical landmarks or skin markers. | Short Navigation Probe | QUANTUM SURGICAL |
3 | 03760305400062 | 02-0027 | 02-0027-19G | The Needle Guide is an instrument of the EPIONE device. It provides mechanical g The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications. | Needle Guide | QUANTUM SURGICAL |
4 | 03760305400055 | 02-0031 | 02-0031 | The Navigation Probe is an instrument of the EPIONE device. It enables visualizi The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verificationof patient registration accuracy, using external anatomical landmarks or skin markers. | Navigation probe | QUANTUM SURGICAL |
5 | 03760305400024 | 02-0026 | 02-0026 | The Patient Reference is an instrument of the EPIONE device used to track the pa The Patient Reference is an instrument of the EPIONE device used to track the patientposition and motions including breathing. | Patient Reference | QUANTUM SURGICAL |
6 | 03760263520017 | 6.0 | LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qual LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to:- visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)- generate automatic reports. | LMS-Lung/TRACK | MEDIAN TECHNOLOGIES | |
7 | EIBAVC110030PL0 | VC-110-030-PL | VC-110-030-PL | 1.10mm x 3.0cm VISICOIL loaded in an 17 gauge brachytherapy needle. | VISICOIL | RADIOMED CORP |
8 | EIBAVC110020PL300 | VC-110-020-PL30 | VC-110-020-PL30 | 1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
9 | EIBAVC110020PL0 | VC-110-020-PL | VC-110-020-PL | 1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
10 | EIBAVC110010PL300 | VC-110-010-PL30 | VC-110-010-PL30 | 1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
11 | EIBAVC110010PL0 | VC-110-010-PL | VC-110-010-PL | 1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
12 | EIBAVC110005PL0 | VC-110-005-PL | VC-110-005-PL | 1.10mm x 0.5cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
13 | EIBAVC075030PL0 | VC-075-030-PL | VC-075-030-PL | 0.75mm x 3.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
14 | EIBAVC075020PL300 | VC-075-020-PL30 | VC-075-020-PL30 | 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
15 | EIBAVC075020PL120 | VC-075-020-PL12 | VC-075-020-PL12 | 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
16 | EIBAVC075020PL0 | VC-075-020-PL | VC-075-020-PL | 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
17 | EIBAVC075010PL300 | VC-075-010-PL30 | VC-075-010-PL30 | 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
18 | EIBAVC075010PL120 | VC-075-010-PL12 | VC-075-010-PL12 | 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
19 | EIBAVC075010PL0 | VC-075-010-PL | VC-075-010-PL | 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
20 | EIBAVC075005PL300 | VC-075-005-PL30 | VC-075-005-PL30 | 0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
21 | EIBAVC075005PL120 | VC-075-005-PL12 | VC-075-005-PL12 | 0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
22 | EIBAVC075005PL0 | VC-075-005-PL | VC-075-005-PL | 0.75mm x 0.50cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
23 | EIBAVC050020PLSL0 | VC-050-020-PLSL | VC-050-020-PLSL | 0.50mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
24 | EIBAVC050020PL0 | VC-050-020-PL | VC-050-020-PL | 0.5mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
25 | EIBAVC050010PLSL0 | VC-050-010-PLSL | VC-050-010-PLSL | 0.5mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
26 | EIBAVC050010PL300 | VC-050-010-PL30 | VC-050-010-PL30 | 0.5mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
27 | EIBAVC050010PL0 | VC-050-010-PL | VC-050-010-PL | 0.50mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
28 | EIBAVC050005PLSL0 | VC-050-005-PLSL | VC-050-005-PLSL | 0.50mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
29 | EIBAVC050005PL300 | VC-050-005-PL30 | VC-050-005-PL30 | 0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
30 | EIBAVC050005PL0 | VC-050-005-PL | VC-050-005-PL | 0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
31 | EIBAVC035040PL0 | VC-035-040-PL | VC-035-040-PL | 0.35mm x 4.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
32 | EIBAVC035030PL0 | VC-035-030-PL | VC-035-030-PL | 0.35mm x 3.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
33 | EIBAVC035020PL0 | VC-035-020-PL | VC-035-020-PL | 0.35mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
34 | EIBAVC035010PL0 | VC-035-010-PL | VC-035-010-PL | 0.35mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
35 | EIBAVC035005PL0 | VC-035-005-PL | VC-035-005-PL | 0.35mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
36 | EIBASNMR03503022200 | SNMR-035-030-2220 | SNMR-035-030-2220 | 0.35mm x 3.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. | VISICOIL MR | RADIOMED CORP |
37 | EIBASNMR03502022200 | SNMR-035-020-2220 | SNMR-035-020-2220 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. | VISICOIL MR | RADIOMED CORP |
38 | EIBASNMR03502022150 | SNMR-035-020-2215 | SNMR-035-020-2215 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachyt 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle. | VISICOIL MR | RADIOMED CORP |
39 | EIBASNMR03502022080 | SNMR-035-020-2208 | SNMR-035-020-2208 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle. | VISICOIL MR | RADIOMED CORP |
40 | EIBASNMR03501022200 | SNMR-035-010-2220 | SNMR-035-010-2220 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. | VISICOIL MR | RADIOMED CORP |
41 | EIBASNMR03501022150 | SNMR-035-010-2215 | SNMR-035-010-2215 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachyt 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle. | VISICOIL MR | RADIOMED CORP |
42 | EIBASNMR03501022080 | SNMR-035-010-2208 | SNMR-035-010-2208 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle. | VISICOIL MR | RADIOMED CORP |
43 | EIBASN050020PL150 | SN-050-020-PL15 | SN-050-020-PL15 | 0.50mm x 2.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
44 | EIBASN050020PL080 | SN-050-020-PL08 | SN-050-020-PL08 | 0.50mm x 2.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
45 | EIBASN050010PL150 | SN-050-010-PL15 | SN-050-010-PL15 | 0.50mm x 1.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
46 | EIBASN050010PL080 | SN-050-010-PL08 | SN-050-010-PL08 | 0.50mm x 1.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
47 | EIBASN050005PL150 | SN-050-005-PL15 | SN-050-005-PL15 | 0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
48 | EIBASN050005PL080 | SN-050-005-PL08 | SN-050-005-PL08 | 0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
49 | EIBASN035020PL150 | SN-035-020-PL15 | SN-035-020-PL15 | 0.35mm x 2.0cm VISICOIL loaded in an 22 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
50 | EIBASN035020PL080 | SN-035-020-PL08 | SN-035-020-PL08 | 0.35mm x 2.0cm VISICOIL loaded in an 22 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |