Identity
- Trade Name
- BSD-500 Hyperthermia System FDA UDI
- Generic Name
- Microwave hyperthermia system FDA UDI
- Device Name
- The BSD-500 Hyperthermia System delivers therapeutic heat to certain surface or subsurface malignant tumors by the external or interstitial application of electromagnetic energy and monitors the temperature of target and surrounding tissues by means of independent temperature sensors. FDA UDI
- Model / Reference
- BSD-500 FDA UDI
- Description
- The BSD-500 Hyperthermia System delivers therapeutic heat to certain surface or subsurface malignant tumors by the external or interstitial application of electromagnetic energy and monitors the temperature of target and surrounding tissues by means of independent temperature sensors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864445000434 FDA UDI
- PMA Number
- P820088 FDA UDI
- FDA Product Code
- LOC FDA UDI
- GMDN Term
- Microwave hyperthermia system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microwave hyperthermia system
BSD-500 Hyperthermia System by Pyrexar Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microwave hyperthermia system.
- HS AMICA — H.S. HOSPITAL SERVICE SPA · Class II
- HS AMICA — H.S. HOSPITAL SERVICE SPA · Class II
- Emprint HP — Covidien LP · Class II
- Emprint — Covidien LP · Class II
- Solero — ANGIODYNAMICS, INC · Class II
- HS AMICA — H.S. HOSPITAL SERVICE SPA · Class II
- Emprint — Covidien LP · Class II
- Evident — Covidien LP · 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 | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pyrexar Medical, Inc.
Sources (1)
- FDA UDI 3667631c-9e05-4a3e-ae17-ef299d1c7432 36 fields · synced Jun 8, 2026