FDA Registration
Active
🇮🇹 Italy
SURGICAL PROCEDURE PACKS
Reg #: 3004361903
·
FEI: 3004361903
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- OMNIA SRL
- Registration Number
- 3004361903
- FEI Number
- 3004361903
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- VIA F.DELNEVO 190
- City
- FIDENZA Parma
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K110724
Owner / Operator
- Firm Name
- Omnia SRL
- Operator Number
- 9059817
- Address
- 1666 E Touhy Ave
- City
- Des Plaines
- State
- IL
- Postal Code
- 60018
- Country
- US
US Agent
- Business Name
- Hu-Friedy Mfg Co LLC
- Contact Name
- Stephanie Wasielewski
- Address
- 1666 E Touhy Ave
- City
- Des Plaines
- State
- IL
- ZIP
- 60018
- Country
- US
- [email protected]
- Phone
- 847 2574500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2011-06-29 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2011-06-29 |
| Drape, Surgical | KKX | Class 2 | General, Plastic Surgery | No | 2011-06-29 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2011-06-29 |
Proprietary Names
SURGICAL PROCEDURE PACKS
Establishment Types
Manufacture Medical Device