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
- 08644450004342 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
- Not 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
BSD-500 Hyperthermia System by Pyrexar Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P820088 also covers:
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 |
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Manufacturer
- Manufacturer
- Pyrexar Medical, Inc.
Sources (1)
- FDA UDI 2854b1bd-495b-4e1f-bb3c-ab5e5ff36df8 37 fields · synced May 30, 2026