FDA Registration
Active
🇮🇹 Italy
0884004 Cross-Linked PE Insert 15° Lipped Diam. 28 Gr. B
Reg #: 3006849754
·
FEI: 3006849754
·
Expires 2025
Products
4
Proprietary Names
22
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- STERIL VERONA s.r.l.
- Registration Number
- 3006849754
- FEI Number
- 3006849754
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via San Giuseppe, 31
- City
- ERBE Verona
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K241059
Owner / Operator
- Firm Name
- STERIL VERONA s.r.l.
- Operator Number
- 10023713
- Address
- Via San Giuseppe, 31
- City
- ERBE'
- State
- Verona
- Postal Code
- 37060
- Country
- IT
- Correspondent
- Ottavio De Santi
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2025-02-21 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2025-02-21 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2025-02-21 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2025-02-21 |
Proprietary Names
0884004 Cross-Linked PE Insert 15° Lipped Diam. 28 Gr. B
0882008 Cross-Linked PE Insert Flat Diam. 28 Gr. D
0888008 Cross-Linked PE Insert Flat Diam. 22 Gr. D
0884008 Cross-Linked PE Insert 15° Lipped Diam. 28 Gr. D
0882006 Cross-Linked PE Insert Flat Diam. 28 Gr. C
0882004 Cross-Linked PE Insert Flat Diam. 28 Gr. B
0884002 Cross-Linked PE Insert 15° Lipped Diam. 28 Gr. A
0880008 Cross-Linked PE Insert 15° Lipped Diam. 36 Gr. D
0882002 Cross-Linked PE Insert Flat Diam. 28 Gr. A
0888004 Cross-Linked PE Insert Flat Diam. 22 Gr. B
0888006 Cross-Linked PE Insert Flat Diam. 22 Gr. C
0885006 Cross-Linked PE Insert Flat Diam. 32 Gr. C
0884006 Cross-Linked PE Insert 15° Lipped Diam. 28 Gr. C
0880006 Cross-Linked PE Insert 15° Lipped Diam. 36 Gr. C
0885004 Cross-Linked PE Insert Flat Diam. 32 Gr. B
0887008 Cross-Linked PE Insert 15° Lipped Diam. 32 Gr. D
0888002 Cross-Linked PE Insert Flat Diam. 22 Gr. A
0887006 Cross-Linked PE Insert 15° Lipped Diam. 32 Gr. C
0878008 Cross-Linked PE Insert Flat Diam. 36 Gr. D
0885008 Cross-Linked PE Insert Flat Diam. 32 Gr. D
0878006 Cross-Linked PE Insert Flat Diam. 36 Gr. C
0887004 Cross-Linked PE Insert 15° Lipped Diam. 32 Gr. B
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)