No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 04260166370034 | S7005 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | FOOT PEDAL | ||
2 | 04260166370317 | S7031 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | EP/IO Box Connection Cable | ||
3 | 04260166371352 | M490021 | SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 3 m | LPB | Cardiac Ablation Percutaneous Catheter | 3 | SMARTABLATE SCom. Recording-/CARTO® Cable | |
4 | 04260166372083 | 4892098 | 4892098 | Stimuplex® HNS 12 Nerv Stimulator with electrode cable / Electrode Cable Orderin Stimuplex® HNS 12 Nerv Stimulator with electrode cable / Electrode Cable Ordering-No. 4892070 | BXN | Stimulator, Nerve, Battery-Powered | 2 | Stimuplex® HNS 12 |
5 | 04260166372045 | M4900633 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | SmartAblate™ System CoolFlow® Pump Cable | ||
6 | 04260166370294 | S7015 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | ECG-Connection Cable with isolated Tips | ||
7 | 04260166370300 | S7030 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | STOCKERT EP/IO Interface Box | ||
8 | 04260166371161 | M490030 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | Connection Cable Irrigation Pump | ||
9 | 04260166371154 | M490028 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | Connection Cable Irrigation Pump | ||
10 | 04260166371147 | M490016 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | Connection Cable Irrigation Pump | ||
11 | 04260166371130 | M490027 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | Connection Cable Irrigation Pump | ||
12 | 04260166370621 | S7032 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml# | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | STOCKERT EP/IO Interface Box | |
13 | 04260166370270 | S7012 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | Valleylab Electrode Connection Cable | ||
14 | 04260166370201 | S7017 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | Stockert-CoolFlow Interface Cable | ||
15 | 04260166370096 | S7008 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | Connection Cable Indifferent Patch-Electrode (3M) | ||
16 | 04260166370041 | S7006 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | GLOBAL PORT | ||
17 | 04260166370430 | M546354 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | Extension Cable for Foot Pedal | ||
18 | 04260166370423 | M546353 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | Extension Cable for Foot Pedal | ||
19 | 04260166370256 | S7019 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | STOCKERT REMOTE CONTROL | ||
20 | 04260166370164 | S7014 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | Connection Cable FO Computer/Digital-ECG | ||
21 | 04260166370065 | 39D-06X15 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | Serial Computer Interface Cable | ||
22 | 04260166370058 | S7013 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | Serial Computer Interface Cable | ||
23 | 04260166371314 | M490013 | SmartAblate Connection Cable Generator - Remote (30 m) | LPB | Cardiac Ablation Percutaneous Catheter | 3 | SmartAblate Gen-Rem Cable | |
24 | 04260166371390 | M490007 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | SmartAblateTM System RF Generator | ||
25 | 04260166371345 | M490023 | SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 15 m | LPB | Cardiac Ablation Percutaneous Catheter | 3 | SMARTABLATE-SCom. Recording-/CARTO® Cable | |
26 | 04260166371758 | M490006 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | SmartAblateTM System | ||
27 | 04260166371475 | 02 | M490005 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | SmartAblateTM System Foot Pedal | |
28 | 04260166371093 | M490008 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | SmartAblateTM System Irrigation Pump | ||
29 | 04260166371321 | M490026 | SmartAblate Foot Pedal extension cable (7 m) | LPB | Cardiac Ablation Percutaneous Catheter | 3 | SmartAblate Foot Pedal ext. Cable | |
30 | 04260166371499 | M490025 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | Serial Data Com. Cable Recording-/CARTO® Systems | ||
31 | 04260166371437 | M490009 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | SmartAblateTM System Remote Control | ||
32 | 04260166371307 | M490029 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | SmartAblate Connection Cable Irrigation Pump | ||
33 | 04260166371338 | M490018 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | ECG Connection Cable | ||
34 | 04260166370539 | S7041 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | Connection Cable Remote Control / RF-Generator | ||
35 | 04260166370515 | S7021 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | Connection Cable Remote Control / RF-Generator | ||
36 | 04260166370195 | S7001 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | STOCKERT 70 | ||
37 | 04260166371611 | M490014 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | Grounding Cable | ||
38 | 04260166371291 | M490010 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | Connection Cable Remote Control | ||
39 | 04260166371284 | M490012 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | Connection Cable Remote Control | ||
40 | 04260166371123 | M490033 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | Connection Cable STOCKERT RF Generator to Pump | ||
41 | 04260166371116 | M490032 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | Connection Cable STOCKERT RF Generator to Pump | ||
42 | 04260166371109 | M490031 | LPB | Cardiac Ablation Percutaneous Catheter | 3 | Connection Cable STOCKERT RF Generator to Pump | ||
43 | 04260166370119 | S7009 | DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | Grounding Cable |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00818087020541 | 901140 | 901140 | Fixed,6 electrode, MPB, 5-5-5-175-175mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
2 | 00818087020534 | 901139 | 901139 | Fixed, 6 electrode, MPA, 5-5-5-175-175mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
3 | 00818087020527 | 901110 | 901110 | Fixed, 6 electrode, MPB, 5-5-5-175-175mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
4 | 00818087020510 | 901109 | 901109 | Fixed, 6 electrode, MPA, 5-5-5-175-175mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
5 | 00818087020503 | 903703 | 903703 | STR, 4 electrode, MPD-CS-S, 5mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
6 | 00818087020442 | 901486 | 901486 | Fixed, 4 electrode, MPB, 2mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
7 | 00818087020435 | 901482 | 901482 | Fixed, 4 electrode, MPA, 2-5-2mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
8 | 00818087020428 | 901478 | 901478 | Fixed, 4 electrode, MPB, 5mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
9 | 00818087020404 | 901714 | 901714 | STR, 10 electrode, MPD-DL, 5mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
10 | 00818087020398 | 903269 | 903269 | Fixed Curve Duo-Decapolar Catheter with Guidewire Tip | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
11 | 00818087020381 | 903226 | 903226 | Fixed Curve Decapolar Catheter with Guidewire Tip | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
12 | 00818087020350 | 903604 | 903604 | Steerable Quadripolar Catheter, Multi-Purpose D Curve-D | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
13 | 00818087020343 | 901602 | 901602 | Steerable Quadripolar Catheter, Multi-Purpose D Curve-B | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
14 | 00818087020336 | 903603 | 903603 | Steerable Quadripolar Catheter, Multi-Purpose D Curve-B | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
15 | 00818087020312 | 901485 | 901485 | Fixed Curve Quadripolar Catheter, Multi-Purpose A Curve | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
16 | 00818087020282 | 901683 | 901683 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-H | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
17 | 00818087020275 | 901680 | 901680 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-H | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
18 | 00818087020268 | 901674 | 901674 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
19 | 00818087020251 | 901673 | 901673 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
20 | 00818087020244 | 901672 | 901672 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
21 | 00818087020237 | 901671 | 901671 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
22 | 00818087020220 | 901670 | 901670 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
23 | 00818087020213 | 903273 | 903273 | Fixed Curve Duo-Decapolar Catheter with Guidewire Tip | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
24 | 00818087020206 | 903271 | 903271 | Fixed Curve Duo-Decapolar Catheter with Guidewire Tip | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
25 | 00818087020190 | 903270 | 903270 | Fixed Curve Duo-Decapolar Catheter with Guidewire Tip | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
26 | 00818087020183 | 903257 | 903257 | Fixed Curve Duo-Decapolar Catheter with Guidewire Tip | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
27 | 00818087020176 | 903256 | 903256 | Fixed Curve Duo-Decapolar Catheter with Guidewire Tip | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
28 | 00818087020169 | 903221 | 903221 | Fixed Curve Decapolar Catheter with Guidewire Tip | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
29 | 00818087020152 | 903219 | 903219 | Fixed Curve Decapolar Catheter with Guidewire Tip | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
30 | 00818087020145 | 903217 | 903217 | Fixed Curve Decapolar Catheter with Guidewire Tip | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
31 | 00818087020138 | 903215 | 903215 | Fixed Curve Decapolar Catheter with Guidewire Tip | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
32 | 00818087020121 | 901824 | 901824 | Fixed Curve Decapolar Catheter, Multi-Purpose A Curve | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
33 | 00818087020114 | 901823 | 901823 | Fixed Curve Decapolar Catheter, Multi-Purpose A Curve | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
34 | 00818087020107 | 901708 | 901708 | Steerable Decapolar Catheter, Multi-Purpose D Curve-SL | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
35 | 00818087020091 | 901707 | 901707 | Steerable Decapolar Catheter, Multi-Purpose D Curve-SL | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
36 | 00818087020084 | 901718 | 901718 | Steerable Decapolar Catheter, Multi-Purpose D Curve-SL | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
37 | 00818087020077 | 901717 | 901717 | Steerable Decapolar Catheter, Multi-Purpose D Curve-SL | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
38 | 00818087020060 | 901645 | 901645 | Steerable Decapolar PV Catheter, Pulmonary Vein 24 | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
39 | 00818087020053 | 901644 | 901644 | Steerable Decapolar PV Catheter, Pulmonary Vein 21 | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
40 | 00818087020046 | 901643 | 901643 | Steerable Decapolar PV Catheter, Pulmonary Vein 18 | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
41 | 00818087020039 | 901642 | 901642 | Steerable Decapolar PV Catheter, Pulmonary Vein 15 | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
42 | 00818087020022 | 901641 | 901641 | Steerable Decapolar PV Catheter, Pulmonary Vein 12 | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
43 | 00818087020015 | 901580 | 901580 | Fixed Curve Decapolar Catheter, Multi-Purpose A Curve | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
44 | 00818087020008 | 901579 | 901579 | Fixed Curve Decapolar Catheter, Multi-Purpose A Curve | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
45 | 00818083019907 | 901577 | 901577 | Fixed, 10 electrode, S, 2-10-2mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
46 | 00818083019877 | 903272 | 903272 | Fixed 4/3.3F tapered, 20 electrode, S, 2-5-2mm electrode spacing, Guidewire Tip | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
47 | 00818083018658 | 903954 | 903954 | STR, 20 electrode, PV24, 7mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
48 | 00818083018641 | 903953 | 903953 | STR, 20 electrode, PV21, 6mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
49 | 00818083018634 | 903952 | 903952 | STR, 20 electrode, PV18, 5mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |
50 | 00818083018627 | 903951 | 903951 | STR, 20 electrode, PV15, 4mm electrode spacing | Map-iT | ACCESS POINT TECHNOLOGIES, INC. |