FDA Registration
Active
🇺🇸 United States
Passer
Reg #: 3007319107
·
FEI: 3007319107
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- PARCUS MEDICAL , L.L.C.
- Registration Number
- 3007319107
- FEI Number
- 3007319107
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6423 Parkland Dr
- City
- Sarasota
- State
- FL
- ZIP
- 34243
- Country
- US
Owner / Operator
- Firm Name
- Medacta International SA
- Operator Number
- 10024526
- Address
- Strada Regina
- City
- Castel San Pietro
- State
- Ticino
- Postal Code
- 6874
- Country
- CH
- Correspondent
- Stefano Baj
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Passer | HWQ | Class 1 | Orthopedic | No | 2025-06-12 |
Proprietary Names
Passer
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device