Identity
- Trade Name
- Sonablate Insertion Pack FDA UDI
- Generic Name
- Ultrasonic hyperthermia system FDA UDI
- Device Name
- A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit FDA UDI
- Model / Reference
- 403-02200-0014 FDA UDI
- Description
- A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868108000267 FDA UDI
- FDA Product Code
- PLP FDA UDI
- GMDN Term
- Ultrasonic hyperthermia system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4340 FDA UDI
- 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
Yes
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: Ultrasonic hyperthermia system
Sonablate Insertion Pack by Focus Surgery, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Focus Surgery, Inc.
Sources (1)
- FDA UDI 797987a4-3b25-4018-b9b6-84f334183c27 33 fields · synced May 30, 2026