FDA Registration
Active
🇫🇷 France
LIGAFIX diameter 6.5 mm router bit, Catalog Number LIG9065072
Reg #: 3004549189
·
FEI: 3004051158
·
Expires 2025
Products
1
Proprietary Names
32
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SCIENCE & BIO MATERIALS, S.B.M. SAS
- Registration Number
- 3004549189
- FEI Number
- 3004051158
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ZI DU MONGE
- City
- LOURDES Hautes-Pyrenees
- Country
- FR
Owner / Operator
- Firm Name
- SCIENCE & BIO MATERIALS
- Operator Number
- 9063735
- Address
- S.B.M. SAS - ZI DU MONGE, --
- City
- Lourdes
- State
- Hautes-Pyrenees
- Postal Code
- 65100
- Country
- FR
- Correspondent
- Anne - COSPIN
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
- 786 7311159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2020-01-09 |
Proprietary Names
LIGAFIX diameter 6.5 mm router bit, Catalog Number LIG9065072
LIGAFIX L 60 mm - diameter 6 mm cannulated drill bit, long flute, Catalog Number LIG9006289
LIGAFIX L 60 mm - diameter 10 mm cannulated drill bit, long flute, Catalog Number LIG9010289
LIGAFIX L 60 mm - diameter 6.5 mm cannulated drill bit, long flute, Catalog Number LIG9065289
LIGAFIX diameter 4.5 mm non-cannulated drill bit, Catalog Number LIG9045FOR
LIGAFIX L 60 mm - diameter 10.5 mm cannulated drill bit, long flute, Catalog Number LIG9105289
LIGAFIX diameter 8.5 mm router bit, Catalog Number LIG9085072
LIGAFIX diameter 7 mm router bit, Catalog Number LIG9070072
LIGAFIX L 60 mm - diameter 11 mm cannulated drill bit, long flute, Catalog Number LIG9011289
LIGAFIX L 60 mm - diameter 8 mm cannulated drill bit, long flute, Catalog Number LIG9008289
PULLUP diameter 4.5 mm cannulated drill bit, Catalog Number PULL000255
LIGAFIX diameter 10.5 mm router bit, Catalog Number LIG9010572
OTIS-C-PLUS diam. 3 mm drill for temporary screw, Catalog Number EVO9035100
RetroTech diam. 4.7 mm cannulated drill bit, Catalog Number PULL000391
LIGAFIX diameter 9.5 mm router bit, Catalog Number LIG9095072
OTIS-C-PLUS diam. 3.5 mm drill - length 195 mm, Catalog Number EVO9069432
LIGAFIX L 60 mm - diameter 8.5 mm cannulated drill bit, long flute, Catalog Number LIG9085289
LIGAFIX diameter 11 mm router bit, Catalog Number LIG9011072
OTIS-F AO diam. 3.2 mm - L 145 mm drill bit, Catalog Number EVO900T878
OTIS-C-PLUS countersink bit, Catalog Number EVO9040203
Drill bit diameter 4 mm - length 450 mm, Catalog Number EVO9069433
LIGAFIX L 60 mm - diameter 9 mm cannulated drill bit, long flute, Catalog Number LIG9009289
LIGAFIX L 60 mm - diameter 7.5 mm cannulated drill bit, long flute, Catalog Number LIG9075289
LIGAFIX diameter 10 mm router bit, Catalog Number LIG9010072
LIGAFIX diameter 7.5 mm router bit, Catalog Number LIG9075072
LIGAFIX L 60 mm - diameter 7 mm cannulated drill bit, long flute, Catalog Number LIG9007289
LIGAFIX L 60 mm - diameter 9.5 mm cannulated drill bit, long flute, Catalog Number LIG9095289
LIGAFIX diameter 9 mm router bit, Catalog Number LIG9090072
LIGAFIX diameter 8 mm router bit, Catalog Number LIG9080072
GlenoTech diameter 5 mm cannulated drill bit, Catalog Number GLE9000426
RetroTech retrograde drill, Catalog Number LIG9000294
OTIS-C-PLUS diam. 4.5 mm drill - length 195 mm, Catalog Number EVO9069434
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device