FDA Registration
Active
🇺🇸 United States
PASCAL System - Stabilizer Rail System
Reg #: 3006128321
·
FEI: 3006128321
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GCX Corporation
- Registration Number
- 3006128321
- FEI Number
- 3006128321
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 26 Spur Dr
- City
- El Paso
- State
- TX
- ZIP
- 79906
- Country
- US
Owner / Operator
- Firm Name
- GCX Corporation
- Operator Number
- 10030734
- Address
- 3875 Cypress Drive
- City
- Petaluma
- State
- CA
- Postal Code
- 94954
- Country
- US
- Correspondent
- Brandon White
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cardiovascular Delivery Catheter System Positioning And Stabilization Device | QWA | Class 1 | Cardiovascular | No | 2023-08-11 |
Proprietary Names
PASCAL System - Stabilizer Rail System
Edwards Reusable Accessories - Reusable Cradle
Edwards Reusable Accessories - Reusable Plate
Edwards Reusable Accessories - Reusable Platform
PASCAL System - Table
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)