Identity
- Trade Name
- Water Path Kit FDA UDI
- Generic Name
- Invasive ultrasound transducer cooling/coupling support kit FDA UDI
- Device Name
- Water Path Kit for use with Sonablate HIFU system. FDA UDI
- Model / Reference
- E01020AST61 FDA UDI
- Description
- Water Path Kit for use with Sonablate HIFU system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868108000205 FDA UDI
- GMDN Term
- Invasive ultrasound transducer cooling/coupling support kit FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
Category: Invasive ultrasound transducer cooling/coupling support kit
Water Path Kit by Focus Surgery, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Invasive ultrasound transducer cooling/coupling support kit.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Focus Surgery, Inc.
Sources (1)
- FDA UDI f948906d-a893-4f3f-8e73-32eae395e8d4 33 fields · synced Jun 8, 2026