FDA Registration
Active
🇺🇸 United States
ProstaLund-CoreTherm Catheter
Reg #: 2025851
·
FEI: 2025851
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Xeridiem Medical Devices
- Registration Number
- 2025851
- FEI Number
- 2025851
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4700 S Overland Dr
- City
- Tucson
- State
- AZ
- ZIP
- 85714
- Country
- US
Regulatory Submissions
- PMA Number
- P010055
Owner / Operator
- Firm Name
- Xeridiem Medical Devices, A Spectrum Plastics Group Company
- Operator Number
- 2025851
- Address
- 4700 SOUTH OVERLAND DR., --
- City
- Tucson
- State
- AZ
- Postal Code
- 85714
- Country
- US
- Correspondent
- Adin Potter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy | MEQ | Class 3 | Unknown | No | 2013-01-29 |
Proprietary Names
ProstaLund-CoreTherm Catheter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)