FDA Registration
Active
🇺🇸 United States
STRATUS MEDICAL
Reg #: 3017423051
·
FEI: 3017423051
·
Expires 2026
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
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Registration Details
- Registration Name
- STRATUS MEDICAL
- Registration Number
- 3017423051
- FEI Number
- 3017423051
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 32303 FM 2978 Rd
- City
- Magnolia
- State
- TX
- ZIP
- 77354
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190259
Owner / Operator
- Firm Name
- Stratus Medical
- Operator Number
- 10077915
- Address
- 32303 FM 2978 Rd
- City
- Magnolia
- State
- TX
- Postal Code
- 77354
- Country
- US
- Correspondent
- Lisa Pelletier
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2020-10-05 |
Proprietary Names
Vesta RF Cannula
MINTA RYAN RF THERMOCOUPLE ELECTRODE
Nimbus RF Multi-tined Expandable Electrode
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198