No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 03661690000144 | EDP900800 | The device is a computer-controlled medical device intended to provide High Inte The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The system consists of the following main sub-assemblies: Therapy Control Module, Treatment Module, Endorectal Probe, and consumable Ablapak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. | PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 2 | Ablatherm Integrated Imaging | |
2 | 03661690000106 | TMS 239269 | TMS 239269 | SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal S SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency. | LNS | Lithotriptor, Extracorporeal Shock-Wave,Urological | 2 | Sonolith i-move Standard Module |
3 | 03661690000083 | TMS 230811 | TMS230811 | One piece carbon fiber table for use with SONOLITH® i-move or i-sys lithotripsy One piece carbon fiber table for use with SONOLITH® i-move or i-sys lithotripsy devices for ESWL(Extracorporeal Shock Wave Lithotnpsy). | MMZ | Table, Cystometric, Electric | 2 | Sonolith Carbon Fiber Table |
4 | 03661690000014 | TMS 227710 | The Ablapak is he single use kit of consumables to support a single patient proc The Ablapak is he single use kit of consumables to support a single patient procedure using the Ablatherm Integrated Imaging system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. | PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 2 | Ablapak | |
5 | 03661690000090 | TMS 233101 | TMS233101 | A table for use with the SONOLITH® i-move medical device is a lithotripter of ES A table for use with the SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). | MMZ | Table, Cystometric, Electric | 2 | Endo-i-move Table |
6 | 03661690000069 | TMS 239305 | TMS 239305 | The Focalpak is the single use kit of consumables to support a single patient pr The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. | PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 2 | Focalpak |
7 | 03661690000243 | EDP 901400 | EDP 901400 | The Focalpak is the single use kit of consumables to support a single patient pr The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. | PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 2 | FocalPak |
8 | 03661690000113 | TMS 239271 | TMS 239271 | SONOLITH® i-move Visio-Track medical device is a lithotripter of ESWL type (Extr SONOLITH® i-move Visio-Track medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency. | LNS | Lithotriptor, Extracorporeal Shock-Wave,Urological | 2 | Sonolith i-move Visio-Track Module |
9 | 03661690000205 | TMS 902081 | TMS 902081 | The Dynamic Focal Probe is a primary component of the Focal One system which is The Dynamic Focal Probe is a primary component of the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via this probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. | PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 2 | Dynamic Focal Probe |
10 | 03661690000151 | TMS 234181 | TMS 234181 | A carbon fiber table with removable right and left panels for use with the SONOL A carbon fiber table with removable right and left panels for use with the SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). | MMZ | Table, Cystometric, Electric | 2 | Carbon Fiber Table W2E |
11 | 03661690000052 | TMS 239320 | The device is a computer-controlled medical device intended to provide High Inte The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The Focal One system consists of the following main sub-assemblies: Focal One Control Module, Dynamic Focal Probe, and consumable Focalpak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.Imported diagnostic data can be fused with the real time ultrasound image in order to facilitate the targeting of the ablation volume. | PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 2 | Focal One | |
12 | 03661690000076 | EDP 900900 | EDP 900900 | The Ablatherm Endorectal Probe is a primary component of the Ablatherm Integrate The Ablatherm Endorectal Probe is a primary component of the Ablatherm Integrated Imaging system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. | PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 2 | Ablatherm Endorectal Probe |
13 | 03661690000045 | TMS 220830 | TMS220830 | The SONOLITH® electrode is the consumable/ disposable component for the SONOLIT The SONOLITH® electrode is the consumable/ disposable component for the SONOLITH® lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency. | MMZ | Table, Cystometric, Electric | 2 | Sonolith Electrode |
14 | 03661690000120 | TMS 239270 | TMS 239270 | SONOLITH® i-move Touch medical device is a lithotripter of ESWL type (Extracorpo SONOLITH® i-move Touch medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency. | LNS | Lithotriptor, Extracorporeal Shock-Wave,Urological | 2 | Sonolith i-move Touch Module |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 03661690000243 | EDP 901400 | EDP 901400 | The Focalpak is the single use kit of consumables to support a single patient pr The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. | FocalPak | EDAP-TMS FRANCE |
2 | 03661690000205 | TMS 902081 | TMS 902081 | The Dynamic Focal Probe is a primary component of the Focal One system which is The Dynamic Focal Probe is a primary component of the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via this probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. | Dynamic Focal Probe | EDAP-TMS FRANCE |
3 | 03661690000199 | EDP 900800 | The device is a computer-controlled medical device intended to provide High Inte The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The system consists of the following main sub-assemblies: Therapy Control Module, Treatment Module, Endorectal Probe, and consumable Ablapak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.Imported diagnostic data can be fused with the real time ultrasound image in order to facilitate the targeting of the ablation volume. | ABLATHERM FUSION | EDAP-TMS FRANCE | |
4 | 03661690000144 | EDP900800 | The device is a computer-controlled medical device intended to provide High Inte The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The system consists of the following main sub-assemblies: Therapy Control Module, Treatment Module, Endorectal Probe, and consumable Ablapak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. | Ablatherm Integrated Imaging | EDAP-TMS FRANCE | |
5 | 03661690000076 | EDP 900900 | EDP 900900 | The Ablatherm Endorectal Probe is a primary component of the Ablatherm Integrate The Ablatherm Endorectal Probe is a primary component of the Ablatherm Integrated Imaging system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. | Ablatherm Endorectal Probe | EDAP-TMS FRANCE |
6 | 03661690000069 | TMS 239305 | TMS 239305 | The Focalpak is the single use kit of consumables to support a single patient pr The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. | Focalpak | EDAP-TMS FRANCE |
7 | 03661690000052 | TMS 239320 | The device is a computer-controlled medical device intended to provide High Inte The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The Focal One system consists of the following main sub-assemblies: Focal One Control Module, Dynamic Focal Probe, and consumable Focalpak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.Imported diagnostic data can be fused with the real time ultrasound image in order to facilitate the targeting of the ablation volume. | Focal One | EDAP-TMS FRANCE | |
8 | 03661690000014 | TMS 227710 | The Ablapak is he single use kit of consumables to support a single patient proc The Ablapak is he single use kit of consumables to support a single patient procedure using the Ablatherm Integrated Imaging system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. | Ablapak | EDAP-TMS FRANCE | |
9 | 00868108000274 | 102-17000-0007 | System used to regulate temperature and oxygen content of sterile water for a procedure. | Sonachill | FOCUS SURGERY INC | |
10 | 00868108000267 | 403-02200-0014 | A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit | Sonablate Insertion Pack | FOCUS SURGERY INC | |
11 | 00868108000229 | 202-17000-0012 | Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy. | Sonablate | FOCUS SURGERY INC | |
12 | 00868108000212 | 102-17000-0009 | Sonasource is comprised of several integrated programmable hardware and software Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control SonaCare Medical's probes. The console includes all electronics required for user interaction with all probe imaging and treatment functions. | Sonasource | FOCUS SURGERY INC | |
13 | 07540281001400 | 111020 | 111020 | TULSA-PRO DISPOSABLE KIT | TULSA-PRO | PROFOUND MEDICAL INC |
14 | 07540281001370 | 109171 | 109171 | TULSA-PRO ENDORECTAL COOLING DEVICE | TULSA-PRO | PROFOUND MEDICAL INC |
15 | 07540281001301 | 109589 | TULSA-PRO® MAGNET KIT – Philips Ingenia 1.5T | TULSA-PRO | PROFOUND MEDICAL INC | |
16 | 07540281001295 | 109609 | DISPOSABLE KIT | TULSA-PRO | PROFOUND MEDICAL INC | |
17 | 07540281001288 | 109312 | TULSA-PRO® MAGNET KIT – SIEMENS BED 515.7mm PITCH (SOLA) | TULSA-PRO | PROFOUND MEDICAL INC | |
18 | 07540281001240 | 108053 | TULSA-PRO® MAGNET KIT – SIEMENS BED 511.5mm PITCH | TULSA-PRO | PROFOUND MEDICAL INC | |
19 | 07540281001233 | 107861 | TULSA-PRO® MAGNET KIT – SIEMENS BED 518.5mm PITCH | TULSA-PRO | PROFOUND MEDICAL INC | |
20 | 07540281001196 | 104843 | TULSA-PRO® MAGNET KIT – SKYRA | TULSA-PRO | PROFOUND MEDICAL INC | |
21 | 07540281000922 | 106955 | Cable - UA to PSIB 3T Siemens | TULSA-PRO | PROFOUND MEDICAL INC | |
22 | 07540281000915 | 107189 | Cable – UA to PSIB, 1.5T Siemens | TULSA-PRO | PROFOUND MEDICAL INC | |
23 | 07540281000908 | 106647 | Cable- UA to PSIB 1.5T Philips 63.87 MHZ | TULSA-PRO | PROFOUND MEDICAL INC | |
24 | 07540281000892 | 106583 | Cable – PS to PSIB,1.5T | TULSA-PRO | PROFOUND MEDICAL INC | |
25 | 07540281000885 | 106582 | CABLE – PS to PSIB, 3.0T | TULSA-PRO | PROFOUND MEDICAL INC | |
26 | 07540281000878 | 106475 | Cable - FB to PSIB, 40 FT | TULSA-PRO | PROFOUND MEDICAL INC | |
27 | 07540281000861 | 106708 | Cable - UA to PSIB, 3T Philips | TULSA-PRO | PROFOUND MEDICAL INC | |
28 | 07540281000847 | 106095 | TULSA-PRO® MAGNET KIT – INGENUITY | TULSA-PRO | PROFOUND MEDICAL INC | |
29 | 07540281000830 | 105392 | TULSA-PRO® MAGNET KIT – INGENIA | TULSA-PRO | PROFOUND MEDICAL INC | |
30 | 07540281000823 | 105391 | TULSA-PRO® MAGNET KIT – PRISMA | TULSA-PRO | PROFOUND MEDICAL INC | |
31 | 07540281000816 | 104969 | TULSA-PRO® MAGNET KIT – ACHIEVA | TULSA-PRO | PROFOUND MEDICAL INC | |
32 | 07540281000212 | 104558 | TULSA-PRO Disposable Kit | TULSA-PRO | PROFOUND MEDICAL INC | |
33 | 07540281000182 | 104011 | TULSA-PRO Tube-set - Endorectal Cooling Device | TULSA-PRO | PROFOUND MEDICAL INC | |
34 | 07540281000175 | 104010 | TULSA-PRO Tube-set Ultrasound Applicator | TULSA-PRO | PROFOUND MEDICAL INC | |
35 | 07540281000168 | 104009 | TULSA-PRO Endorectal Cooling Device | TULSA-PRO | PROFOUND MEDICAL INC | |
36 | 07540281000151 | 104008 | TULSA-PRO Ultrasound Applicator | TULSA-PRO | PROFOUND MEDICAL INC | |
37 | 07540281000144 | 106515 | TULSA-PRO Positioning System Interface Box | TULSA-PRO | PROFOUND MEDICAL INC | |
38 | 07540281000137 | 106604 | TULSA-PRO Filter Box | TULSA-PRO | PROFOUND MEDICAL INC | |
39 | 07540281000120 | 106585 | TULSA-PRO Positioning System | TULSA-PRO | PROFOUND MEDICAL INC | |
40 | 07540281000113 | 105486 | Cable - UA to PSIB, 128MHz | TULSA-PRO | PROFOUND MEDICAL INC | |
41 | 07540281000106 | 105485 | Cable - UA to PSIB, 123MHz | TULSA-PRO | PROFOUND MEDICAL INC | |
42 | 07540281000090 | 103708 | Cable - FB to PSIB, 40 FT | TULSA-PRO | PROFOUND MEDICAL INC | |
43 | 07540281000083 | 103705 | Cable - SE to FB, 25FT | TULSA-PRO | PROFOUND MEDICAL INC | |
44 | 07540281000076 | 104495 | TULSA-PRO Treatment Delivery Console | TULSA-PRO | PROFOUND MEDICAL INC | |
45 | 07540281000069 | 104494 | TULSA-PRO Positioning System Interface Box | TULSA-PRO | PROFOUND MEDICAL INC | |
46 | 07540281000052 | 104493 | TULSA-PRO Filter Box | TULSA-PRO | PROFOUND MEDICAL INC | |
47 | 07540281000045 | 104492 | TULSA-PRO System Cart | TULSA-PRO | PROFOUND MEDICAL INC | |
48 | 07540281000038 | 104491 | TULSA-PRO Positioning System | TULSA-PRO | PROFOUND MEDICAL INC | |
49 | 07540281000021 | 104470 | TULSA-PRO System Electronics | TULSA-PRO | PROFOUND MEDICAL INC | |
50 | 07540281000014 | PAD-105 | TULSA-PRO System | TULSA-PRO | PROFOUND MEDICAL INC |