FDA Registration
Active
🇺🇸 United States
Virtua Medical Image Disc Recorder
Reg #: 1530958
·
FEI: 1000639866
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- CODONICS, INC.
- Registration Number
- 1530958
- FEI Number
- 1000639866
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 17991 Englewood Dr
- City
- Middleburg Heights
- State
- OH
- ZIP
- 44130
- Country
- US
Owner / Operator
- Firm Name
- CODONICS, INC.
- Operator Number
- 9026554
- Address
- 17991 ENGLEWOOD DR., --
- City
- Middleburg Heights
- State
- OH
- Postal Code
- 44130
- Country
- US
- Correspondent
- Vincent - Yee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2007-12-14 |
Proprietary Names
Virtua Medical Image Disc Recorder
Virtua XR Medical Image Disc Recorder
Virtua E Medical Device Recorder
Virtua C Medical Device Recorder
Establishment Types
Remanufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device