FDA Registration
Active
🇫🇷 France
7mm screwdriver
Reg #: 3015383864
·
FEI: 3015383864
·
Expires 2025
Products
1
Proprietary Names
30
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- S.M.A.I.O
- Registration Number
- 3015383864
- FEI Number
- 3015383864
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 Place Berthe Morisot, Parc Technologique
- City
- SAINT-PRIEST Auvergne-Rhone-Alpes
- Country
- FR
Owner / Operator
- Firm Name
- S.M.A.I.O
- Operator Number
- 10077967
- Address
- 2 Place Berthe Morisot, Parc Technologique
- City
- SAINT-PRIEST
- State
- Auvergne-Rhone-Alpes
- Postal Code
- 69800
- Country
- FR
- Correspondent
- Jean-Charles Roussouly
US Agent
- Business Name
- DAWA MEDICAL LLC
- Contact Name
- Stephan Toupin
- Address
- 7320 NW 12th street suite 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 305 5999373
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2020-12-16 |
Proprietary Names
7mm screwdriver
Short straight extension
Sacral screw drill
Nut breaker counter torque
Rod holder
Sacral connector holder
Distractor
Nut breaker
9mm nut driver
Long straight extension
Plate holder
Right 60deg S2 cap guide
Axial connector holder
Rod gripper
Sacral screw holder
Nut breaker sleeve
Tulip connector holder
1/4" straight handle
Parallel connector holder
1/4" T-rachet handle
Connector holder
Sacral plate drilling guide
1/4" straight medium handle
Left 60deg S2 cap guide
Sacral plate extension breaker
1/4" T-handle
Right 90deg S2 cap guide
Left 90deg S2 cap guide
1/4" straight ratchet handle
Pedicle screw counter torque
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device