Identity
- Trade Name
- FocalPak EUDAMEDFDA UDI
- Generic Name
- Physical therapy ultrasound system FDA UDI
- Device Name
- FocalPak/FocalPak Endo EUDAMEDThe 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. FDA UDI
- Model / Reference
- EDP 901400 EUDAMEDFDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- EDP 901400 FDA UDI
- Primary DI / UDI-DI
- 03661690000243 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661690FOCALPAK2B EUDAMED
- 510(k) Number
- K172721 FDA UDI
- FDA Product Code
- PLP FDA UDI
- EMDN Code
- U1299 SINGLE-USE UROGENITAL INSTRUMENTATION (NON-ENDOSCOPIC) - OTHER EUDAMED
- GMDN Term
- Physical therapy ultrasound system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4340 FDA UDI
- Medical Purpose
- Focalpak/FocalPak Endo are accessories of the Focal One. There are designed for acoustic coupling and cooling between tissues and endorectal probe. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
FocalPak by Edap-Tms France — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3661690FOCALPAK2B | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Edap Tms France
- EUDAMED SRN
- FR-PR-000011354
Sources (2)
- EUDAMED 47a91ad5-84f6-4058-b37a-25cccad53ad0 61 fields · synced Jul 20, 2026
- FDA UDI 03241da6-ac08-4f70-800d-65c60cbce653 37 fields · synced May 30, 2026