Ablapak
GUDID 03661690000014
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.
EDAP-TMS FRANCE
Physical therapy ultrasound system| Primary Device ID | 03661690000014 |
| NIH Device Record Key | 823d77db-07dc-466b-a9bc-008f3b949f2a |
| Commercial Distribution Discontinuation | 2024-05-24 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Ablapak |
| Version Model Number | TMS 227710 |
| Company DUNS | 383113362 |
| Company Name | EDAP-TMS FRANCE |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661690000014 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153023
FDA Product Code
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-12-11 |
| Device Publish Date | 2018-06-08 |
Devices Manufactured by EDAP-TMS FRANCE
| 03661690000014 - Ablapak | 2024-12-11The 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. |
| 03661690000014 - Ablapak | 2024-12-11 The Ablapak is he single use kit of consumables to support a single patient procedure using the Ablatherm Integrated Imaging sys |
| 03661690000076 - Ablatherm Endorectal Probe | 2024-12-11 The Ablatherm Endorectal Probe is a primary component of the Ablatherm Integrated Imaging system which is a computer-controlled |
| 03661690000083 - Sonolith Carbon Fiber Table | 2024-12-11 One piece carbon fiber table for use with SONOLITH® i-move or i-sys lithotripsy devices for ESWL(Extracorporeal Shock Wave Lith |
| 03661690000090 - Endo-i-move Table | 2024-12-11 A table for use with the SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy) |
| 03661690000106 - Sonolith i-move Standard Module | 2024-12-11 SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle |
| 03661690000113 - Sonolith i-move Visio-Track Module | 2024-12-11 SONOLITH® i-move Visio-Track medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physica |
| 03661690000120 - Sonolith i-move Touch Module | 2024-12-11 SONOLITH® i-move Touch medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical prin |
| 03661690000144 - Ablatherm Integrated Imaging | 2024-12-11 The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HI |
Trademark Results [Ablapak]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ABLAPAK 75832166 2590307 Live/Registered |
EDAP TMS FRANCE 1999-10-27 |
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