Identity
- Trade Name
- Sonablate Insertion Pack EUDAMEDFDA UDI
- Generic Name
- Invasive ultrasound transducer cooling/coupling support kit FDA UDI
- Device Name
- Sonablate HIFU consumables EUDAMED
- Model / Reference
- 404-14500-0003 EUDAMED403-02200-0002-I FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850071153095 EUDAMEDFDA UDI
- Basic UDI-DI
- 00850071153HIFUpackUS EUDAMED
- EMDN Code
- Z12160385 PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Invasive ultrasound transducer cooling/coupling support kit FDA UDI
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- The Sonablate HIFU Procedure Pack is a combination of products, including medical devices, accessories, and non-medical devices, packaged together, and placed on the market with the purpose of being used in conjunction with the Sonablate System to complete a procedure. 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
Yes
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
Sonablate Insertion Pack by Focus Surgery, Inc. — Class I — 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 | 00850071153HIFUpackUS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Focus Surgery, Inc.
- EUDAMED SRN
- US-PR-000045638
Sources (2)
- EUDAMED e3562641-05bf-4a0b-8b22-3395cd91cd61 61 fields · synced Jul 21, 2026
- FDA UDI f048413f-10bf-459e-b72a-0f546b067cd3 32 fields · synced May 30, 2026