Identity
- Trade Name
- Prolieve FDA UDI
- Generic Name
- Microwave hyperthermia system FDA UDI
- Device Name
- Prolieve Thermodilatation System FDA UDI
- Model / Reference
- Original FDA UDI
- Description
- Prolieve Thermodilatation System FDA UDI
Identifiers
- Primary DI / UDI-DI
- B0638808060 FDA UDI
- GMDN Term
- Microwave hyperthermia system FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microwave hyperthermia system
Prolieve by Medifocus, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Microwave hyperthermia system.
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- Emprint — Covidien LP · Class II
- BSD-2000 Hyperthermia System — Pyrexar Medical, Inc. · Unclassified
- Solero — ANGIODYNAMICS, INC · Class II
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
- Medifocus, Inc.
Sources (1)
- FDA UDI 38c9d4f2-7a30-4798-b33b-0b2de9572c5b 33 fields · synced May 30, 2026