FDA Registration
Active
🇫🇷 France
Bicortical depth gauge
Reg #: 3015383864
·
FEI: 3015383864
·
Expires 2025
Products
1
Proprietary Names
6
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 |
|---|---|---|---|---|---|
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2020-12-16 |
Proprietary Names
Bicortical depth gauge
Straight feeler depth gauge
Straight feeler
Straight pedicle probe
Pedicle marker
Curved pedicle probe
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility