FDA Registration
Active
🇮🇹 Italy
Arthrex Bone Cement Open Mixing Bowl
Reg #: 3010898856
·
FEI: 3010898856
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- G21 S.R.I.
- Registration Number
- 3010898856
- FEI Number
- 3010898856
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via S. Pertini, 8
- City
- San Possidonio Modena
- Country
- IT
Owner / Operator
- Firm Name
- G21 s.r.l.
- Operator Number
- 10051231
- Address
- Via S. Pertini, 8
- City
- San Possidonio
- State
- Modena
- Postal Code
- 41039
- Country
- IT
- Correspondent
- Maurizio Foroni
US Agent
- Business Name
- RQMIS, Inc.
- Contact Name
- Barry Sands
- Address
- 110 Haverhill Road, Suite 524
- City
- Amesbury
- State
- MA
- ZIP
- 01913
- Country
- US
- [email protected]
- Phone
- 609 3728223
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2016-02-21 |
Proprietary Names
Arthrex Bone Cement Open Mixing Bowl
PICOMIX BOWL:BONE CEMENT CLOSED MIXING SYSTEM
PICOMIX SYRINGE BONE CEMENT MIXING SYSTEM (120GR)
PICOMIX V, MIXING SYSTEM AND DELIVERY SYRINGES
DISP MIXING BOWL-O: OPEN MIXING SYSTEM FOR BONE CEMENT PREPARATION
PICOMIX SYRINGE BONE CEMENT MIXING SYSTEM (180GR)
Arthrex Bone Cement Mixing Syringe
Arthrex Bone Cement Closed Mixing Bowl
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device